[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-coronary-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-coronary-syndrome":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,105,0,25,[9,57,93,123,147,187,216,246,272,302,335,364,388,415,434,463,485,519,550,575,596,621,648,675,725],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100394478","phase-4-potassium-competitive-acid-blocker-versus-proton-pump-inhibitor-for-gastroprotection-strategies-in-patients-at-high-gastro-intestinal-bleeding-risk-receiving-antithrombotic-therapy-100394478",false,"NCT04416581","Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy","A Multi-centre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase 4 Efficacy and Safety Study of P-CAB (Tegoprazan 50 mg Once Daily) Compared With PPI (Rabeprazole 20 mg Once Daily) to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease","PROTECT-HBR","Inclusion Criteria:\n\n1. Patients 19 years of age or older with known cardiac and vascular disease who are receiving chronic use of antithrombotic drugs (either antiplatelets, oral anticoagulant (OAC), and its combinations). Specific clinical conditions that may confer a need for long-term antithrombotic therapy may include documented coronary artery disease (stable or unstable angina, acute coronary syndrome, a history of myocardial infarction, or any coronary revascularization), documented cerebrovascular disease (stroke or transient ischemic attack), known peripheral arterial disease or a history of peripheral arterial revascularization, atrial fibrillation, or valvular heart disease requiring interventions (transcatheter aortic valve replacement or transcatheter mitral-valve repair). Concomitant use of a proton pump inhibitor is strongly recommended in patients receiving aspirin monotherapy, DAPT (dual antiplatelet therapy; aspirin plus any P2Y12 inhibitors), DAT (dual antithrombotic therapy; antiplatelet drug plus OAC), TAT (triple antithrombotic therapy; DAPT plus OAC), or OAC monotherapy (warfarin or direct oral anticoagulants) who are at high risk of GI bleeding in order to reduce the risk of gastric bleed or GI events. Based on clinical guidelines, the use of P2Y12 inhibitor monotherapy (i.e. clopidogrel, ticagrelor, or prasugrel) is not considered in trial enrollment.\n2. On the basis of clinical guidelines and expert consensus documents, we defined a study population with an increased risk of gastrointestinal bleeding if they had a least 1 or more criteria of the following characteristics. Eligible patients for randomization must meet at least 1 characteristic of these criteria:\n\n   \\*Definition of patients who are at high risk of gastrointestinal bleeding\n   1. Age ≥65 years\n   2. Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or TAT)\n   3. Long-term use of oral NSAIDs (non-steroidal anti-inflammatory drugs) or steroids or high-dose NSAID therapy even during a relatively short-term period.\n   4. History of prior GI bleeding events at any time\n   5. History of a previously complicated ulcer\n   6. History of peptic ulcer disease or a previously uncomplicated ulcer\n   7. Documented Helicobacter pylori infection\n3. Patients who voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Active bleeding at the time of inclusion or a history of hereditary or acquired hemostatic disorder\n2. Any clinical contraindication to using of antithrombotic therapies (antiplatelet agents or OAC)\n3. Concurrent use of PPI or P-CAB within 4 weeks before randomization\n4. Hemodynamically unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV).\n5. Baseline severe anemia (Hgb \\\u003C8 g\u002Fdl at baseline) or transfusion within 4 weeks before randomization\n6. Baseline severe thrombocytopenia (platelet count \\\u003C50,000\u002Fmm3)\n7. Renal failure dependent on dialysis or severe renal insufficiency (creatinine clearance \\\u003C15 ml\u002Fmin)\n8. Severe chronic liver disease (defined as variceal haemorrhage, ascites, hepatic encephalopathy, or jaundice)\n9. Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or substituted benzimidazoles\n10. Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter pylori eradication\n11. Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide for Helicobacter pylori eradication\n12. Systemic treatment with strong CYP 3A4 and p-glycoprotein (P-GP) inhibitors (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus \\[HIV\\]-protease inhibitors, such as ritonavir)\n13. Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see Drug-Drug interaction section)\n14. Clinically significant laboratory abnormality at screening (estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin or elevated liver enzyme \\[AST, ALT, ALP, total bilirubin\\] \\> 3 times upper normal limit \\[UNL\\] or any other condition that, in the opinion of the Investigator, precludes participation in the study\n15. Any known or suspected malignancy\n16. Patients with non-cardiac co-morbidities with a life expectancy of less than 12 months\n17. Patients with active treatment for H-pylori infection\n18. Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening\n19. Participation in another clinical study within 12 months. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;\n\n    1. Participated in the observational study expected no effect on the safety and\u002For effectiveness evaluation of this trial\n    2. Screening failed before any interventional factor is involved\n    3. Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies","ALL","19 Years",{"count":21,"type":22},3320,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.",[28,29,30,31],"Coronary Artery Disease","Percutaneous Coronary Intervention","Acute Coronary Syndrome","Myocardial Infarction",[33,34,35,36,37,38,39,40,41,42,43],"gastroduodenal ulcer","gastrointestinal hemorrhage","peptic ulcer","acute coronary syndrome","coronary artery stent placement","antiplatelet","anticoagulant therapy","PPI","P-CAB","Proton-pump inhibitors","Potassium-Competitive Acid Blockers","RECRUITING","2026-06-24",{"date":47,"type":48},"2026-06-26","ACTUAL",{"date":50,"type":48},"2021-05-12",{"date":52,"type":22},"2028-02-28",{"name":54,"class":55},"Duk-Woo Park, MD","OTHER",45,{"id":58,"slug":59,"hasResults":12,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100545664","diagnostic-performance-of-artificial-intelligence-algorithms-in-prediction-of-acute-coronary-syndrome-based-on-white-blood-cell-properties-100545664","NCT06384846","Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties","Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties (AI-ACS Trial)","Inclusion Criteria:\n\nGeneral inclusion criteria:\n\n* Male or female, aged 18 years or above.\n* Participant is willing and able to give informed consent for participation in the study.\n* Collection of WBC and hs-cTn data must be possible.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled, where applicable.\n\nCase cohort:\n\n* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.\n* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.\n* For patients qualifying for observation according to ESC guidelines, coronary angiography is not mandatory and time limits do not apply.\n* Confirmation of STEMI or NSTE-ACS by identification of a culprit lesion using coronary angiography; identical evaluation results by review board required.\n* For observation patients without coronary angiography, final discharge diagnosis is used to decide about the presence or absence of NSTEMI and\u002For ACS.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nControl cohort:\n\n* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.\n* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.\n* No identification of a culprit lesion compatible with diagnosis of STEMI or NSTE-ACS during coronary angiography; identical evaluation results by review board required.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nSupplementary cohort:\n\n* Subject presents without chest pain or with stable angina pectoris.\n* No indication for revascularization during coronary angiography; identical evaluation results by review board required.\n* Exclusion of elevated hs-cTn.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n* Between initial blood sampling to collect WBC data and coronary angiography, the subject must not develop suspicion of ACS.\n\nRule-out cohort:\n\n* Suspicion of NSTE-ACS and NSTEMI rule-out according to current ESC guidelines, i.e. very low initial hs-cTn value, or low initial hs-cTn value and no significant 1-hour\u002F2-hour change in hs-cTn value.\n* No coronary angiography within 72 hours.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nAll-comer cohort:\n\n* Subject presents to the emergency department with suspected ACS.\n* Clinical assessments, ECG, and measurements of hs-cTn, single or serial measurement, must be conducted according to ESC guidelines.\n* Collection of WBC data must be performed at initial blood withdrawal after admission to the emergency department.\n* Review board evaluations must confirm the presence or absence of a culprit lesion if coronary angiography was performed, as outlined for the case and control cohorts.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Subject refuses informed consent.\n* Collection of WBC and hs-cTn data is not possible.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data cannot be fulfilled.\n* Suspicion of ACS occurs in subjects with no or stable angina pectoris any time between initial blood sampling and start of coronary angiography.",true,"18 Years",{"count":67,"type":22},3350,"OBSERVATIONAL","The goal of this observational study is to evaluate whether artificial intelligence (AI) algorithms can predict or exclude acute coronary syndrome (ACS) in adults using data generated by routine hematology testing. The main questions the study aims to answer are:\n\n* Can AI algorithms based on white blood cell (WBC) data predict or exclude ACS in subjects with suspected ACS?\n* Can erythrocyte (EC) and\u002For thrombocyte (TC) data, where available, improve or complement WBC-based AI prediction of ACS?\n* How does the diagnostic performance of the AI algorithms compare with high-sensitivity cardiac troponin (hs-cTn), and can the combination of AI algorithms and hs-cTn improve diagnostic performance?\n\nParticipants will undergo clinical assessment and blood testing as part of usual clinical care. Their previously generated clinical information, hematology data, and hs-cTn results will be used to train and test the AI algorithms. Participation in the study does not determine the indication for coronary angiography or treatment, and no additional study-specific treatments are performed.",[30,71,72,73,74],"Angina Pectoris","NSTEMI - Non-ST Segment Elevation MI","STEMI - ST Elevation Myocardial Infarction","Unstable Angina (UA)",[76,77,78,79,80,81,82],"Artificial Intelligence","AI","hematology analyzer","ACS","white blood cell","Troponin","Machine learning","2026-06-21",{"date":45,"type":48},{"date":86,"type":48},"2024-02-01",{"date":88,"type":22},"2026-12-31",{"name":90,"class":91},"RobotDreams GmbH","INDUSTRY",1,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":79,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100600833","phase-3-evaluation-of-efficacy-and-safety-of-early-in-hospital-initiation-of-inclisiran-treatment-in-patients-with-acute-coronary-syndromes-100600833","NCT07102628","Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes","A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes: Victorion - RIDES","Inclusion Criteria:\n\nParticipant eligible for inclusion in this study must meet all the following criteria:\n\nAt Screening:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Males and females, ≥18 years of age at the time of providing written informed consent.\n3. Ability to understand study's requirements and provide informed consent and comply with all required study procedures.\n4. Hospitalization for a ACS event (STEMI or NSTEMI).\n5. Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization.\n6. Had a successful PCI (with or without stent) for the qualifying event if a PCI was required.\n7. LDL-C value at the Screening visit measured by the local lab of:\n\n   * LDL-C ≥70 mg\u002FdL in participant previously treated with high-intensity statin (atorvastatin ≥40 mg\u002Fday or rosuvastatin ≥20 mg\u002Fday) or equivalent as per national guidelines and local regulation for at least 4 weeks before screening or\n   * LDL-C ≥100 mg\u002FdL in participant previously treated with low\u002Fmoderate-intensity statin for at least 4 weeks before screening or\n   * LDL-C ≥125 mg\u002FdL in participant previously not treated with statins for at least 4 weeks before screening, or who never received statins (including statin intolerant participants).\n\n   At Randomization:\n8. The participant must have a Baseline fasting LDL-C ≥70 mg\u002FdL (local lab assessment) to be eligible for randomization.\n9. Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before\u002Fat discharge.\n\nExclusion Criteria:\n\nParticipant meeting any of the following criteria is not eligible for inclusion in this study.\n\nOnly for Japan: For exclusion criteria 6, investigator judgment should be documented in the source data document.\n\n1. Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomization:\n\n   * Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \\\u003C90 mmHg due to cardiac failure with associated symptoms requiring inotropes\n   * Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter)\n   * Cardiogenic shock or mechanical complication of myocardial infarction\n   * New York Heart Association (NYHA) class IV heart failure\n   * Left ventricular ejection fraction \\\u003C20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive or non-invasive assessment modalities)\n   * Uncontrolled severe hypertension: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg prior to randomization despite antihypertensive therapy.\n2. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event.\n3. Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation \\>3x ULN or aspartate aminotransferase (AST) elevation \\>3x ULN, or total bilirubin elevation \\>2x ULN (except participant with Gilbert's syndrome) at the Screening visit, in the context of an ACS, and assessed as related to the index event and\u002For treatment procedures (such as PCI). Eligibility will be based on Investigator's judgement for participant who will be randomized.\n4. Renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) at the Screening visit.\n5. Fasting triglycerides value \\>400 mg\u002FdL (4.52 mmol\u002FL; assessed by local labs) at randomization visit.\n6. Participant, who based on the Investigator's judgement, could reach the LDL-C target value of \\\u003C55 mg\u002FdL after 4 weeks on statin treatment only.\n7. Secondary hypercholesterolemia (based on medical history).\n8. Homozygous familial hypercholesterolemia (based on medical history).\n9. Participant on apheresis at the Screening visit.\n10. Ongoing or medical history of myopathy at the Screening visit.\n11. CK values ≥5x ULN at Screening visit and confirmed by repeat test during Screening (local lab) , in the context of an ACS, and assessed as related to the index event and\u002For treatment procedures (such as PCI) eligibility will be based on Investigator's judgement for participant who will be randomized (who will be switched to or initiated on the protocol-specified dose of high-intensity statin of atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD). Unless a more stringent CK value threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in Korea according to MFDS internal guideline).",{"count":101,"type":22},300,[103],"PHASE3","The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.",[30],[107,30,79,108,109,110,111,112],"KJX839","NSTEMI","STEMI","Inclisiran","LDL-C","Hyperlipidemia","2026-06-19",{"date":115,"type":48},"2026-06-23",{"date":117,"type":48},"2025-10-03",{"date":119,"type":22},"2027-02-11",{"name":121,"class":91},"Novartis Pharmaceuticals",63,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100509855","phase-3-effect-of-dalcetrapib-on-cv-risk-in-a-genetically-defined-population-with-a-recent-acs-100509855","NCT05918861","Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS","Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)","dal-GenE-2","Inclusion Criteria:\n\n* Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.\n* Both male and female subjects age 45 years and over at screening visit (V1)\n* AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)\n* Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization\n* Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.\n* Randomization within 3 months of the index ACS event\n\nExclusion Criteria:\n\n* Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding\n* Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \\>12 months) who are not using at least one highly effective method of contraception.\n* New York Heart Association (NYHA) Class III or IV heart failure\n* Index ACS event presumed due to uncontrolled hypertension\n* Systolic blood pressure (BP) \\>180 mmHg and\u002For diastolic blood pressure \\>110 mmHg at the time of randomization despite anti-hypertensive therapy\n* Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level \\>3 x ULN within 6 months prior to randomization (excluding index event)\n* History of persistent and unexplained creatine phosphokinase (CPK) levels \\> 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)\n* Last known eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 as assessed within 6 months prior to randomization\n* History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.\n* Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study\n* Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial\n* Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization","45 Years",{"count":133,"type":22},2000,[103],"This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.",[30],"2026-06-17",{"date":139,"type":48},"2026-06-22",{"date":141,"type":48},"2023-10-03",{"date":143,"type":22},"2027-08",{"name":145,"class":91},"DalCor Pharmaceuticals",231,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":160,"conditions":161,"keywords":174,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":92},"100612800","safety-and-clinical-performance-of-the-freesolve-resorbable-magnesium-scaffold-rms-system-in-subjects-with-coronary-artery-lesions-100612800","NCT07258290","Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions","Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries","BIOMAG-III","Clinical Inclusion Criteria:\n\n1. Subject is ≥ 18 years and ≤ 80 years of age\n2. Subject has provided written informed consent as approved by the Ethics Committee \u002F Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures\n3. Subject is eligible for PCI according to the applicable guidelines\n4. Subject is an acceptable candidate for coronary artery bypass surgery\n5. Subjects with stable or unstable angina pectoris, documented silent ischemia\u002Fabnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion\n\n   Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:\n   * Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \\[lesion(s) causing the acute STEMI\\];\n   * Subject is hemodynamically stable with documented declining cardiac biomarkers;\n   * Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)\n6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine\n7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)\n8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study\n\nAngiographic Inclusion Criteria:\n\n1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries\n2. Target vessel must have a reference diameter between 2.5-4.2 mm by operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) \u002F Intravascular Ultrasound (IVUS) \u002F Optical Coherence Tomography (OCT)\n3. Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT, (or \\\u003C 20 mm for target lesion(s) to be treated with a study device \\\u003C 3.0 mm in diameter) and must be amenable to treatment with a single study device\n4. Target lesion stenosis ≥ 50% and \\\u003C 100% by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT. Target lesion stenosis \\\u003C 70% by visual estimation, should have clinical justification for treatment as per local standards.\n5. Target lesion must have a Thrombolysis in Myocardial Infarction (TIMI) flow ≥ 1\n\nClinical Exclusion Criteria:\n\n1. Subject is pregnant and\u002For breastfeeding or intends to become pregnant during the duration of the study\n2. Subject has clinical symptoms and\u002For electrocardiogram (ECG) changes consistent with STEMI \\\u003C 72 hours prior to the index procedure Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment\n3. Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \\\u003C 72 hours prior to the index procedure\n4. Subject is on dialysis or has impaired renal function (serum creatinine \\> 2.5 mg\u002FdL or 221 µmol\u002FL, determined within 7 days prior to the index procedure)\n5. Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminum, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, methacrylic polymer, and fluoropolymer)\n6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)\n7. Life expectancy less than 1 year\n8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained\n9. In the investigator's opinion subject will not be able to comply with the follow-up requirements\n10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e., triple therapy) can be maintained for a minimum of 1 month\n11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure\n12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT\n13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug\n14. Subject has known severe aortic or mitral valve stenosis\u002Finsufficiency or has previously undergone transcatheter aortic valve replacement (TAVR)\n\nAngiographic Exclusion Criteria:\n\n1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion\n2. Left main coronary artery disease\n3. Target lesion is totally occluded (100% stenosis)\n4. Thrombus in target vessel\n5. Future planned staged PCI either in target or non-target vessel\n6. Ostial target lesion within the left anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA) (within 5.0 mm of vessel origin)\n7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation\n8. Target lesion is located in or supplied by an arterial or venous bypass graft\n9. Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and\u002For cutting\u002Fscoring balloon as described in angiographic exclusion criteria 10\n10. Target lesion requires treatment with a device other than the non-compliant balloon and\u002For cutting\u002Fscoring balloon prior to scaffold\u002Fstent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons, etc.)\n11. Target vessel was treated with brachytherapy any time prior to the index procedure.\n12. Unsuccessful pre-dilatation, defined as residual stenosis \\> 20% (by visual estimation) and\u002For angiographic complications (e.g., distal embolization, side branch closure, flow-limiting dissections)","80 Years",{"count":157,"type":22},1859,[159],"NA","The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system",[162,163,164,165,166,167,168,169,170,171,172,28,173,30,71],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Arteriosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Chest Pain","Pain","Neurologic Manifestations","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Myocardial Ischemia",[175,176,177,178],"Resorbable Magnesium Scaffold","Sirolimus","RMS","Drug eluting absorbable metal scaffold","2026-06-15",{"date":137,"type":48},{"date":182,"type":48},"2026-06-11",{"date":184,"type":22},"2033-06",{"name":186,"class":91},"Teleflex",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":23,"phases":197,"briefSummary":198,"conditions":199,"keywords":203,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":92},"100415858","phase-4-dual-antithrombotic-therapy-with-dabigatran-and-ticagrelor-in-patients-with-acs-and-non-valvular-af-undergoing-pci-100415858","NCT04695106","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)","ADONIS-PCI","Inclusion Criteria:\n\n* Male and female patients aged ≥18 years'\n* Patients with new-onset or pre-existing non-valvular AF that have been receiving oral anticoagulant treatment with dabigatran for at least 48 hours or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis unless long-term treatment with an OAC is anticipated.\n* Patients presenting with ACS that had undergone a successful PCI with drug-eluting stent (DES) implantation or plain old balloon angioplasty within the previous 120 hours. ACS may be ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina (UA). Successful treatment with PCI is defined as achievement of \\\u003C30% residual diameter stenosis of the target lesion assessed by visual inspection or quantitative coronary angiography and no in-hospital major adverse cardiac events (AMI or repeat coronary revascularisation of the target lesion). For ACS patients with ST-segment elevation, persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block should be present. For ACS patients without ST-segment elevation, at least two of the following three criteria should be met: (i) ST-segment changes on electrocardiography, indicating ischemia; (ii) a positive test of a biomarker, indicating myocardial necrosis; or (iii) one of several risk factors (age ≥60 years; previous myocardial infarction or coronary artery bypass grafting; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease; chronic renal dysfunction, defined as a creatinine clearance of \\\u003C60 ml per minute per 1.73 m2 of body surface area).\n* The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and\u002For regulations.\n\nExclusion Criteria:\n\n* Mechanical or biological heart valve prosthesis;\n* PCI with bare-metal stent insertion;\n* Unsuccessful PCI (\\>30% residual stenosis of the target lesion);\n* Cardiogenic shock during current hospitalization;\n* Adverse bleeding or ischaemic event during current hospitalization;\n* Anaemia (haemoglobin \\\u003C10 g\u002FdL) or thrombocytopenia (platelet count \\\u003C100 x109\u002FL) at screening,\n* Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin (estimated CrCl calculated by Cockcroft-Gault equation) at screening;\n* Active liver disease at screening defined as persistently elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) \\>3-fold upper limit of normal (ULN)\n* Use of fibrinolytic agents within 24 hours of screening;\n* Gastrointestinal bleeding within 1 month prior to screening unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g., by surgery);\n* Major bleeding episode (reduction in the hemoglobin level of at least 2 g\u002FdL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ), including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the hemoglobin level of at least 5 g\u002FdL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) within 1 month prior to screening;\n* Stroke within 1 month prior to screening;\n* Major surgery within 1 month prior to screening;\n* Malignancy or radiation therapy within 6 months prior to screening unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months;\n* History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired;\n* Hemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery\u002Fintervention);\n* Past an organ transplant or patient on the waiting list for organ transplant;\n* Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic\u002Fmyelosuppressive therapy.\n* Need for continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs);\n* Pre-menopausal women (last menstruation ≤1 year prior to screening) who: sre pregnant or breastfeeding or are not surgically sterile or are of childbearing potential and not practicing two acceptable methods of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial. Acceptable methods of birth control are oral or parenteral (patch, injection, implant) hormonal contraception, which has been used continuously for at least one month prior to the first dose of study medication, intrauterine device or intrauterine system, double-barrier method of contraception (condom and occlusive cap or condom and spermicidal agent), male sterilization and complete sexual abstinence (if acceptable by local authorities). Periodic abstinence is not an acceptable method of contraception.\n* Known allergy to dabigatran, ticagrelor, clopidogrel, aspirin, or to the excipients used for the tables of the drugs;\n* Contraindications, in the Investigator's opinion to dabigatran, ticagrelor, clopidogrel, or aspirin;\n* Participation in another trial with an investigational drug or device within the past 30 days preceding the screening visit (patients participating in an observational study only will not be excluded);\n* Patients who are not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and\u002For compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease, or who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).",{"count":196,"type":22},1194,[25],"More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI.\n\nThis is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months.\n\nWe expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.",[200,201,30,202],"Atrial Fibrillation","Antithrombotic Therapy","Percutaneous Coronary Interventions",[200,30,204,205,206],"Dabigatran","Ticagrelor","Antithrombotic therapy","2026-06-14",{"date":209,"type":48},"2026-06-16",{"date":211,"type":48},"2021-10-25",{"date":213,"type":22},"2026-08-31",{"name":215,"class":55},"Medical University of Gdansk",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":233,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100517174","predictive-value-of-glycemic-parameters-measured-with-the-fsl-pro-iq-during-acs-100517174","NCT06014112","Predictive Value of Glycemic Parameters Measured With the FSL Pro iQ During ACS","Predictive Value of Glycemic Parameters Measured With the Freestyle Libre Pro iQ During Acute Coronary Syndrome","FREESCA","Inclusion Criteria:\n\n* Patients with ACS managed in a cardiac intensive care unit (ICU). The diagnosis of ACS will be made in the presence of chest pain with ST-segment elevation on the ECG for STEMI or ST-segment change and\u002For a positive troponin cycle (values in accordance with the center's protocol) for NSTEMI.\n\nExclusion Criteria:\n\n* Subjects in cardiogenic or septic shock\n* Subjects with ACS initially managed in a non-investigating center\n* Failure to obtain free, informed, written consent signed by the participant and investigator upon admission to the ICU\n* Person participating in another research study with an ongoing exclusion period\n* Subjects participating in a study that may have an impact on post ACS prognosis\n* Person deprived of his or her rights, person under guardianship or curatorship\n* Person deprived of liberty (by judicial or administrative decision)\n* Persons whose physical and\u002For psychological health is severely impaired, which, in the opinion of the investigator, may affect the participant's compliance to the study\n* Pregnant or breastfeeding women\n* Person who is not affiliated to a social security system or who is a beneficiary of such a system.","85 Years",{"count":226,"type":22},850,[159],"Disorders of glycemic regulation are common in patients hospitalized for acute coronary syndrome (ACS). Abnormal glycaemia is observed in 50% of cases, in 30-40% diabetes, and in 25-35% fasting hyperglycaemia or glucose intolerance.\n\nHyperglycemia is a major prognostic factor in ACS, with admission hyperglycemia having independent prognostic value for both short- and long-term major cardiovascular events (MACE), regardless of the presence of diabetes.\n\nMetabolically, several situations can be distinguished:\n\n* Hyperglycaemia occurs in known non-diabetic ACS subjects. It can be indicative of (i) Type 2 Diabetes or (ii) stress hyperglycaemia (diagnostic threshold for blood sugar varies according to learned societies, with HbA1c \\\u003C 6.5%).\n* Hyperglycaemia occurs in known diabetic ACS subjects Most studies use admission blood sugar as a predictor. However, it has recently been shown that glycemic variability indexes would be better predictors of MACE. Using continuous glucose measurement for 48 h, it has been shown that significant glycemic variability is a more powerful predictor of MACE at 1 year than admission glycemia The measurement of glycemic variability is mainly possible thanks to the development of CGM (continuous glucose measurement).\n\nTo our knowledge, no study has been interested in evaluating the predictive value of the various glycemic parameters measured by CGM.\n\nPublished studies have used continuous glucose measurements for very short periods (24 or 72 hours maximum), which limits these measurements.\n\nThe freestyle libre Pro iQ (FSLPro iQ) is a professional sensor for continuous, non-invasive interstitial glucose measurement allowing the recording of glycemic parameters for 2 weeks.\n\nOur hypothesis is that glycaemic parameters, alone or in combination with each other or with other patient risk factors, measured with the Freestyle libre Pro iQ have a significant prognostic value in terms of cardiovascular clinical events at 12 months in a population of patients with ACS managed as standard and followed up.",[30,230,231,232],"Continuous Glucose Measurement","Glycemic Variability","Cardiovascular Event",[36,234,235,236],"continuous glucose measurement","glycemic variability","cardiovascular event",{"date":238,"type":48},"2026-06-12",{"date":240,"type":48},"2023-11-06",{"date":242,"type":22},"2028-05-06",{"name":244,"class":55},"University Hospital, Montpellier",9,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":254,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":271},"100475637","phase-3-doxycycline-host-directed-therapy-to-improve-lung-function-and-decrease-tissue-destruction-in-pulmonary-tuberculosis-100475637","NCT05473520","Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis","Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis: A Phase III Randomized Control Trial (Doxy-TB)","Doxy-TB","The recruitment target would be 150 patients, with 75 in each arm\n\nInclusion criteria: Patients should meet all criteria:\n\n1. Aged 21 years and above\n2. Patients receiving ≤ 14 days of TB treatment or about to start standard combination TB treatment\n3. Confirmed pulmonary TB with positive acid-fast bacilli smear and\u002For positive nucleic acid amplification test (NAAT) and\u002For TB culture results\n4. CXR demonstrating pulmonary involvement with cavity or cavities\n5. Able to provide informed consent\n\nExclusion criteria:\n\n1. HIV co-infection\n2. Previous pulmonary TB\n3. Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer\n4. Pregnant or breast feeding\n5. Allergies to tetracyclines\n6. Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity\n7. Autoimmune disease and\u002For on systemic immunosuppressants\n8. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of study drug, or planned use during the study period\n9. Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung\n10. Evidence of severe depression, schizophrenia or mania\n11. ALT \\> 3 times upper limit of normal\n12. Creatinine \\> 2 times upper limit of normal\n13. Principal investigator assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome","21 Years",{"count":256,"type":22},150,[103],"Tuberculosis (TB) is a global pandemic that despite successful treatment and bacterial eradication can cause chronic ill health, such as pulmonary impairment after tuberculosis (PIAT) and cardiovascular disease (CVD). A recent Phase 2b double-blind randomised-controlled clinical trial shows that adjunctive doxycycline therapy is safe, accelerates resolution of inflammation, suppresses tissue damaging enzyme activity and decreases pulmonary cavity volume (1). We aim to determine if adjunctive doxycycline can reduce PIAT and improve cardiovascular outcomes in a fully powered Phase III trial of 8 weeks of adjunctive doxycycline alongside standard pulmonary TB (PTB) treatment.\n\nThe investigators hypothesize that doxycycline inhibits tissue destruction in patients with PTB and thereby leads to improved lung function after treatment.\n\nSpecific aims\n\n1. To assess improvement in lung function as measured by forced expiratory volume (FEV1) predicted in PTB patients given doxycycline versus placebo.\n2. To investigate whether doxycycline will hasten the resolution of pulmonary cavities measured by CT thorax\n3. To investigate whether doxycycline can suppress inflammatory markers including matrix metalloproteinases\n4. To investigate whether doxycycline can accelerate time to sputum conversion\n5. To evaluate the effect of doxycycline on cardiovascular outcomes such as the incidence of acute coronary syndrome (ACS) and pulmonary hypertension\n6. To investigate whether doxycycline improves TB drug concentrations in sputum and plasma.\n7. To assess the safety profile of doxycycline with concurrent standard anti-tuberculous treatment.",[260,30,261],"Tuberculosis","Pulmonary Hypertension (Diagnosis)","2026-06-08",{"date":264,"type":48},"2026-06-09",{"date":266,"type":48},"2023-05-24",{"date":268,"type":22},"2030-01-31",{"name":270,"class":55},"National University Hospital, Singapore",6,{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":280,"targetDuration":281,"studyType":68,"phases":4,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":293,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":92},"100636249","polymer-free-sirolimus-eluting-stent-real-world-investigation-of-safety-and-outcomes-100636249","NCT07563231","Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes","POLARIS","Inclusion Criteria:\n\n* Age \\>= 18 years at the time of the index procedure.\n* Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.\n* Implantation of at least one study device\n* Indication for PCI according to current European or American guidelines.\n* Able and willing to provide written informed consent.\n* Sufficient knowledge of French, German, English, or Italian to understand the patient information document.\n\nExclusion Criteria:\n\n* Documented refusal to participate in research through opt-out from general consent.\n* Inability to provide informed consent (cognitive impairment or other).\n* Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).\n* Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.\n* Participation in another clinical trial that would interfere with the endpoints of this registry.",{"count":101,"type":22},"5 Years","POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.",[28,30,31,284,29],"Stent Thrombosis",[286,287,288,289,290,291,292],"drug-eluting stent","polymer-free stent","sirolimus","percutaneous coronary intervention","target lesion failure","registry","real-world evidence","NOT_YET_RECRUITING","2026-06-05",{"date":264,"type":48},{"date":297,"type":22},"2026-06",{"date":299,"type":22},"2036-06",{"name":301,"class":55},"Dorian Garin",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":318,"overallStatus":293,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":92},"100640379","in-hospital-wearable-based-monitoring-versus-standard-care-in-cardiovascular-disease-inspire-100640379","NCT07622485","In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)","In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)","Inclusion Criteria:\n\nAdults aged 20 years or older\n\n* Hospitalized for cardiovascular disease, with at least one of: acute coronary syndrome; chronic coronary syndrome; acute heart failure (NYHA class III-IV or acute decompensated heart failure); arrhythmia (atrial fibrillation, ventricular tachycardia, complete AV block, or other clinically significant arrhythmia); peripheral arterial or aortic disease; post-cardiovascular-procedure observation (PCI, CABG, valve surgery, or electrophysiology study); or thromboembolic disease\n* Able to provide written informed consent\n* Able to wear the wearable monitoring device\n\nExclusion Criteria:\n\n* Hemodynamically unstable shock (sustained systolic blood pressure \\\u003C 90 mmHg requiring vasopressors; cardiogenic shock; septic shock)\n* Planned or current intensive care unit admission\n* Within 24 hours after cardiopulmonary resuscitation\n* Physical condition precluding device wearing (bilateral upper-limb amputation; severe skin lesion, burn, or open wound at the device site; known allergy to device materials)\n* Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use\n* Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible)\n* Unable to communicate in Korean for study explanation and the consent process\n* Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission)\n* Considered inappropriate for participation by the investigator","20 Years",{"count":311,"type":22},1500,[159],"Patients hospitalized with cardiovascular disease require timely detection of clinical deterioration to prevent adverse outcomes. Standard inpatient care relies on intermittent nursing vital-sign measurements performed every 4 to 8 hours, which can miss hemodynamic or arrhythmic events occurring between measurements. This trial evaluates whether digital wearable-based monitoring - wireless continuous measurement of vital signs and electrocardiography with a real-time alerting system - reduces major adverse cardiovascular events (MACE) compared with standard intermittent monitoring in patients hospitalized for cardiovascular disease. The trial uses a stepped-wedge cluster-randomized design in which four inpatient ward zones (clusters) are sequentially transitioned from standard care to wearable monitoring over five periods.",[164,30,315,316,317],"Heart Failure","Cardiac Arrhythmia","Peripheral Arterial Disease",[319,320,321,322,323,324,325],"wearable device","continuous monitoring","remote monitoring","stepped-wedge cluster trial","major adverse cardiovascular events","digital health","inpatient monitoring","2026-06-01",{"date":328,"type":48},"2026-06-03",{"date":330,"type":22},"2026-07-01",{"date":332,"type":22},"2029-12-31",{"name":334,"class":55},"Yonsei University",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":344,"briefSummary":345,"conditions":346,"keywords":350,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100638293","feasibility-study-of-a-digital-interactive-life-style-platform-for-individuals-after-rehabilitation-100638293","NCT07597031","Feasibility Study of a Digital Interactive Life-style Platform for Individuals After Rehabilitation","Feas Platf","Inclusion Criteria:\n\n* Adults (≥18 years)\n* 10 or less days before discharge from inpatient rehabilitation at the Bern Rehab Center in Heiligenschwendi or the Insel Hospital (both belonging to the Insel Group)\n* Belonging to one of the following clinical cohorts: acute coronary syndrome or ischemic heart failure; chronic obstructive pulmonary disease (COPD) - clinically diagnosed and confirmed by pulmonary specialist; fragility fracture - e.g., hip fracture or other low-energy fractures; minor stroke, clinically confirmed ischemic or hemorrhagic stroke with mild neurological deficits.\n* Able to provide informed consent.\n* Access to and ability to use a device that has internet access (e.g., tablet, smartphone, laptop, etc.).\n\nExclusion Criteria:\n\n* Cognitive or psychiatric condition interfering with consent or use of the app.\n* Physical disability preventing digital device use without support.\n* Heavy language production or comprehension impairments.",{"count":343,"type":22},240,[159],"The goal of this clinical trial is to evaluate the feasibility and usability of a digital lifestyle platform designed to support patients after discharge from inpatient rehabilitation. It will also assess patient engagement and the potential of the platform to support long-term self-management and healthy lifestyle behaviors in an outpatient setting.\n\nThe main questions it aims to answer are:\n\nIs the platform feasible and acceptable for patients after rehabilitation? Do patients engage with and regularly use the platform over time? Can personalized digital recommendations support adherence to healthy behaviors and self-management?\n\nResearchers will evaluate a telemedicine platform that delivers individualized suggestions, including lifestyle applications, educational content, and advice from healthcare professionals. The content is tailored to patient needs and continuously adapted based on patient feedback.\n\nParticipants will:\n\nUse the digital platform after discharge from inpatient rehabilitation for a defined follow-up period Receive personalized recommendations through the platform Rate the usefulness of recommendations to enable continuous adaptation Attend study visits or remote assessments to evaluate usability, engagement, and outcomes Continue standard outpatient care alongside the intervention",[347,30,348,349],"Chronic Obstructive Pulmonary Disease (COPD)","Fragility Fracture","Minor Stroke",[351,352,353],"Telemedicine","Phase III rehabilitation","Long-term non-communicable diseases","2026-05-18",{"date":356,"type":48},"2026-05-19",{"date":358,"type":22},"2026-05-01",{"date":360,"type":22},"2027-02-01",{"name":362,"class":55},"Matthias Wilhelm, MD",2,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":64,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":92},"100523107","florbetaben-for-imaging-of-vascular-amyloid-100523107","NCT06091319","Florbetaben for Imaging of Vascular Amyloid","Florbetaben for Imaging of Vascular Amyloid: Evaluation of Amyloid Inflammasome Imaging in Carotid and Coronary Arteries in Patients With Unstable Atherosclerosis- A Pilot Study","FERMATA","Inclusion Criteria:\n\n1. suffered a recent cardiovascular event (30-120 days post ACS (i.e. STEMI or NSTEMI) or TIA\u002Fstroke with ipsilateral large vessel atherosclerotic disease confirmed on US, CT or MRI;\n2. stable symptoms and hemodynamics;\n3. age \\>\u002F= 18 years;\n4. given informed consent.\n\nExclusion Criteria:\n\n1. a recent CV event likely to have been embolic in the opinion of the neurologist or cardiologist;\n2. severe LV dysfunction (EF\\\u003C30%);\n3. severe valve disease requiring intervention;\n4. decompensated heart failure;\n5. pregnancy (all women of child bearing potential will have a negative BHCG test;\n6. breastfeeding;\n7. women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception;.\n8. unable to give informed consent;.\n9. Florbetaben allergy;\n10. glomerular filtration rate (GFR) \\\u003C50 ml\u002Fmin\u002F1.72m2\n\nExclusion for CTA portion of the protocol: Patients with dye allergy, or those with GFR \\\u003C60, will not undergo CTA but will have PET\u002FCT.",{"count":373,"type":22},30,"The Primary Objective is to determine if a new nuclear tracer (named 18F-Florbetaben) used with nuclear imaging (PET imaging) can detect inflamed plaque in patients with recent ACS or stroke\u002FTIA.",[30,376,377,378],"Stroke","Transient Ischemic Attack","Atherosclerosis of Artery","2026-05-05",{"date":381,"type":48},"2026-05-08",{"date":383,"type":48},"2023-10-09",{"date":385,"type":22},"2026-08-01",{"name":387,"class":55},"Ottawa Heart Institute Research Corporation",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":412,"locationsCount":414},"100618290","artificial-intelligence-driven-medipixel-fractional-flow-reserve-versus-invasive-fractional-flow-reserve-guided-pci-trial-aim-ffr-trial-100618290","NCT07329699","Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)","Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI","AIM-FFR","Inclusion Criteria:\n\n1. Subject must be at least 19 years of age\n2. Eligible for coronary angiography and\u002For percutaneous coronary intervention.\n3. Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)\n4. Coronary artery disease in one or more native major epicardial vessels or their branches with reference vessel diameter of at least 2.5mm and with visually assessed coronary stenosis in which the physiological severity of the lesion is questionable (typically 40-90% diameter stenosis).\n5. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Patients unable to provide informed consent\n2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons\n3. Patients with coronary artery bypass grafting\n4. Patients who have non-cardiac co-morbid conditions with life expectancy \\\u003C1 year\n5. Patients with cardiogenic shock or cardiac arrest\n6. Patients with severe left ventricular systolic dysfunction (ejection fraction \\\u003C30%)\n7. Patients with severe valvular heart disease requiring open heart surgery\n8. Pregnant or lactating women\n9. Angiographic exclusion criteria\n\n   * Culprit vessel of patients with ST-elevation myocardial infarction (target lesions in non-culprit vessel can be enrolled)\n   * Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled)\n   * Ostial stenosis in left man coronary artery or right coronary artery\n   * Severe tortuosity of any target vessel\n   * Severe overlap in the stenosed segment\n   * Poor image quality precluding identification of vessel contours",{"count":397,"type":22},2100,[159],"The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.",[28,401,30],"Chronic Coronary Syndrome",[403,404,405],"Coronary artery stenosis","Fractional flow reserve","Prognosis","2026-04-21",{"date":408,"type":48},"2026-04-23",{"date":410,"type":48},"2026-03-18",{"date":332,"type":22},{"name":413,"class":55},"Samsung Medical Center",23,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":293,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100635316","relationship-between-inflammatory-hs-crp-neutrophil-to-lymphocyte-ratio-and-cardiac-troponin-biomarkers-and-cardiac-dysfunction-in-acute-coronary-syndrome-100635316","NCT07551102","Relationship Between Inflammatory (Hs-CRP, Neutrophil-to-Lymphocyte Ratio) and Cardiac (Troponin) Biomarkers, and Cardiac Dysfunction in Acute Coronary Syndrome.","Inclusion Criteria:\n\n* • Adult patients (≥18 years)\n\n  * Patients diagnosed with Acute Coronary Syndrome (STEMI, NSTEMI, or unstable angina)\n  * Presentation within 24 hours of symptoms onset\n  * Informed consent\n\nExclusion Criteria:\n\n* • Chronic inflammatory diseases\n\n  * Active infection\n  * Malignancy\n  * Severe hepatic or renal failure\n  * Autoimmune diseases\n  * Patients with known cardiomyopathy or chronic reduced ejection fraction\n  * Patients with ACS treated with thrombolysis",{"count":422,"type":22},144,"Acute Coronary Syndrome (ACS) remains a leading cause of morbidity and mortality worldwide, accounting for a significant proportion of cardiovascular-related deaths. Early diagnosis and accurate risk stratification are crucial for improving clinical outcomes and guiding therapeutic decisions. Cardiac troponins (I and T) are highly sensitive and specific biomarkers of myocardial injury and represent the gold standard for the diagnosis of ACS (1).\n\nIn recent years, inflammation has been recognized as a key contributor to the pathophysiology of atherosclerosis and plaque instability. Inflammatory biomarkers such as high-sensitivity C-reactive protein (hs-CRP) and the neutrophil-to-lymphocyte ratio (NLR) have gained attention as predictors of adverse cardiovascular outcomes. Elevated hs-CRP levels are associated with increased risk of myocardial infarction and poor prognosis (2), while NLR reflects the balance between inflammatory activation and immune regulation and has been linked to severity of coronary artery disease and mortality in ACS patients (3).\n\nEchocardiography remains a cornerstone in the assessment of cardiac function, providing essential information about left ventricular ejection fraction (LVEF) and regional wall motion abnormalities (RWMA). More recently, speckle tracking echocardiography (STE) has emerged as a sensitive tool for detecting subclinical myocardial dysfunction through parameters such as global longitudinal strain (GLS), even before a reduction in LVEF becomes apparent (4,5).\n\nDespite the established individual roles of cardiac and inflammatory biomarkers, limited data are available regarding their combined effect on cardiac function, particularly when integrated with advanced echocardiographic techniques. Therefore, this study aims to evaluate the relationship between inflammatory biomarkers (hs-CRP, NLR), cardiac biomarker (troponin), and echocardiographic findings in patients with ACS to enhance early risk stratification and improve clinical decision-making.",[30],"2026-04-19",{"date":427,"type":48},"2026-04-24",{"date":429,"type":22},"2026-05",{"date":431,"type":22},"2026-12",{"name":433,"class":55},"Assiut University",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":92},"100470976","positive-emotions-following-acute-cardiac-events-100470976","NCT05412862","Positive Emotions Following Acute Cardiac Events","A Novel Psychological-behavioral Intervention to Promote Physical Activity After Acute Coronary Syndrome","PEACE-V","Inclusion Criteria:\n\n* ACS (myocardial infarction or unstable angina)\n* Suboptimal physical activity (score of \\\u003C 6 on the Medical Outcomes study Specific Adherence Scale item related to physical activity)\n\nExclusion Criteria:\n\n* Cognitive deficits (assessed via a 6-item cognitive screening tool)\n* Medical conditions likely to lead to death within 6 months.\n* Moderate-severe depression (Patient Health Questionnaire-9 \\[PHQ-9\\] score ≥15)\n* Inability to participate in physical activity due to another medical condition (e.g., arthritis)\n* Inability to read, write, or speak in English\n* Inability to receive text-messages\n* Current participation in another intervention or program that has been designed to promote well-being or physical activity","95 Years",{"count":444,"type":22},280,[159],"The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.",[30,448],"Physical Inactivity",[450,451,452,453],"Positive psychology","Physical Activity","Motivational Interviewing","Adherence","2026-04-15",{"date":456,"type":48},"2026-04-20",{"date":458,"type":48},"2022-09-12",{"date":460,"type":22},"2028-03-31",{"name":462,"class":55},"Massachusetts General Hospital",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":92},"100610689","a-study-evaluating-the-vascular-healing-and-neointimal-transformation-at-1-month-after-implantation-of-biofreedom-drug-coated-stents-and-the-xience-drug-eluting-stent-system-in-patients-with-acute-coronary-syndrome-and-high-bleeding-risk-using-optical-coherence-tomography-100610689","NCT07230847","A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Male or non-pregnant female\n3. Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI)\n4. No contraindications for coronary artery bypass grafting (CABG)\n5. High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria):\n\n   Major Criteria:\n   * Expected long-term oral anticoagulation\n   * Severe\u002Fend-stage chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin)\n   * Moderate\u002Fsevere anemia (Hb \\\u003C110 g\u002FL)\n   * Spontaneous bleeding requiring hospitalization\u002Ftransfusion within 6 months (or recurrent)\n   * Chronic bleeding diathesis\n   * Moderate\u002Fsevere thrombocytopenia pre-PCI (platelet count \\\u003C100×10⁹\u002FL)\n   * Liver cirrhosis with portal hypertension\n   * Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis\u002Ftreatment within 12 months)\n   * History of spontaneous intracranial hemorrhage\n   * Traumatic intracranial hemorrhage within 12 months\n   * Known cerebral arteriovenous malformation\n   * Moderate\u002Fsevere ischemic stroke within 6 months\n   * Major surgery\u002Fsevere trauma within 30 days pre-PCI\n   * Planned non-deferrable major surgery during dual antiplatelet therapy\n\n   Minor Criteria:\n   * Age ≥75 years\n   * Moderate chronic kidney disease (eGFR:30\\~59 ml\u002Fmin)\n   * Mild anemia (male: Hb=110\\~129 g\u002FL; female: Hb=110\\~119 g\u002FL)\n   * Spontaneous bleeding requiring hospitalization\u002Ftransfusion within 6-12 months pre-PCI\n   * Chronic NSAID\u002Fsteroid use post-PCI\n   * Ischemic stroke \\>6 months pre-PCI\n6. Capable of understanding trial objectives and providing informed consent\n\nAngiographic Inclusion Criteria:\n\n1. Target lesion must be primary native coronary artery lesion\n2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence\n3. ≥1 non-target lesion requiring intervention\n4. Non-target lesions eligible for elective treatment within 1 month\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n1. Presence of ≥1 evidence of heart failure including:\n\n   * NYHA Class III or higher, or\n   * Killip classification ≥ Grade 2, or\n   * Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography)\n2. Cardiogenic shock patients\n3. Known allergies to: Aspirin \u002F clopidogrel \u002F ticagrelor \u002F heparin, Contrast agents\u002Fdrugs used in drug-eluting stents or contraindications to aspirin\u002F clopidogrel \u002F ticagrelor\n4. Life expectancy \\\u003C12 months or factors potentially compromising clinical follow-up\n5. Participation in other drug\u002Fmedical device trials prior to enrollment without reaching primary endpoint timelines\n6. History of substance abuse (alcohol\u002Fcocaine\u002Fheroin, etc.)\n7. Severe arrhythmias (e.g., high-risk ventricular premature contractions\u002F ventricular tachycardia)\n8. Other medical conditions deemed unsuitable by investigators\n\nAngiographic Exclusion Criteria:\n\n1. Left main coronary artery disease\n2. Bypass graft lesions\n3. Evidence of extensive thrombus in target vessel",{"count":470,"type":22},60,[159],"BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedom™'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.",[474,30],"Coronary Heart Disease","2026-03-31",{"date":477,"type":48},"2026-04-06",{"date":479,"type":48},"2025-12-10",{"date":481,"type":22},"2027-03-31",{"name":483,"class":484},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":493,"minAge":65,"maxAge":494,"enrollmentInfo":495,"targetDuration":497,"studyType":68,"phases":4,"briefSummary":498,"conditions":499,"keywords":502,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":518},"100550044","prospective-multicenter-registry-of-gender-diversity-and-inclusion-gedi-of-women-with-acute-coronary-syndrome-100550044","NCT06441942","Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome","Creation of a Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) in Phenotypic and Genetic Characterization of Acute Coronary Syndrome.","ACS GEDI","Inclusion Criteria:\n\n* Women \\>\u002F= 18 years with ACS (STEMI, NSTEMI or Unstable Angina).\n\nExclusion Criteria:\n\n* age \\\u003C 18 years and\u002For unwillingness to sign informed consent and\u002For unwillingness to make follow-up visits","FEMALE","100 Years",{"count":496,"type":22},100,"12 Months","Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS). This registry aims to understand the diversity in the presentation of women with ACS. It proposes to conduct a thorough characterization of the women involved in the study through genetic, biochemical, and molecular analysis.This approach aims to identify any differences in the characteristics of women with ACS and to identify disease subtypes that may influence treatment options and clinical outcomes.",[30,500,501],"Gender","Genetic Predisposition",[79,503,504,505,506,507,508],"GEDI","Genetic","DNA","mRNA","Proteomic","Metabolomic","2026-03-30",{"date":511,"type":48},"2026-04-03",{"date":513,"type":48},"2025-01-28",{"date":515,"type":22},"2027-02-28",{"name":517,"class":55},"IRCCS San Raffaele",4,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":549},"100156656","revascularization-strategies-in-patients-with-non-st-segment-elevation-acute-coronary-syndrome-nste-acs-and-severe-coronary-artery-disease-100156656","NCT01311323","Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease","Multivessel and Left Main Coronary Artery Stenting in Comparison With Surgical Revascularization in Patients With Non ST Elevation Acute Coronary Syndrome. Prospective, Clinical Randomized Trial (The MILESTONE Trial)","MILESTONE","Inclusion Criteria:\n\nSubjects must meet ALL of the inclusion criteria to be considered for the trial. If ANY of the exclusion criteria are met, the subject is excluded from the trial and cannot be randomized.\n\n* Age over 18 years,\n* Written patient consent,\n* Acute Coronary Syndrome without ST-segment elevation of high, intermediate and low risk, including NSTEMI and unstable angina requiring urgent (within 72 hours) invasive strategy,\n* Qualification for invasive treatment,\n* Multivessel coronary disease, defined as angiographic narrowing \\>50%DS on investigator's visual assessment in at least two major coronary artery territories (RCA, LAD, LCX), including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \\\u003C 33. Intermediate lesions (40-70%) will need to be assessed with either FFR, iFR, or VFFR). Patient may have left main coronary artery disease, defined as narrowing \\>50%DS (but this is not obligatory). For borderline changes, IVUS (MLA \\\u003C6 mm2 or iFR=\\\u003C0,90 or FFR=\\\u003C0,80, with an anatomic Syntax Score \\\u003C33 will be decisive,\n* Feasibility of complete revascularization on both the CABG and PCI sides,\n* Consent within the Heart Team for both CABG by the cardiothoracic surgeon and PCI by the interventional cardiologist.\n\nExclusion Criteria:\n\n* Age under 18 years,\n* ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB),\n* Stable coronary syndrome,\n* Single- or two-vessel coronary disease without involvement of the proximal LAD, defined as narrowing above 50%DS,\n* Qualification for conservative treatment,\n* Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation,\n* Need for immediate coronary angioplasty treatment,\n* Syntax Score equal or above 33 (\\>=33),\n* Contraindications to short-term and long-term antiplatelet therapy,\n* Acute heart failure in class IV (cardiogenic shock),\n* Previous CABG procedure,\n* Previous PCI procedure within the last 6 months,\n* Ischemic or hemorrhagic stroke within 6 months prior to inclusion,\n* End-stage chronic kidney disease on dialysis,\n* Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization),\n* Non cardiac co-morbidities with life expectancy less than 3 years,\n* Participation in other clinical trial that have not reached their primary endpoint.",{"count":528,"type":22},1000,[159],"MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and\u002For with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC\u002FAHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).\n\nSimilarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction.\n\nIn the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE \\\u003C5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.",[532,30],"Multivessel Coronary Artery Disease",[532,534,29,535,536,537,538,539],"Left Main Narrowing","Coronary Artery Bypass Grafting","Drug-Eluting Stent","Fractional Flow Reserve","Instant wave-free ratio","virtual Fractional Flow Reserve","2026-02-20",{"date":542,"type":48},"2026-02-23",{"date":544,"type":48},"2025-08-25",{"date":546,"type":22},"2030-11",{"name":548,"class":55},"American Heart of Poland",7,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":245},"100557820","phase-4-mact-mono-antiplatelet-and-colchicine-therapy-prospective-multicenter-study-100557820","NCT06543082","MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study","Clinical Outcomes of Colchicine Therapy Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study","MACT II","Inclusion Criteria:\n\n* Participants with positive troponin acute coronary syndrome who have undergone implantation of ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG).\n* Participants who have provided written informed consent.\n\nExclusion Criteria:\n\n* Under 19 years of age.\n* Stent treatment failure lesions (stent restenosis or thrombosis).\n* Cardiac arrest or cardiogenic shock.\n* Currently taking or requiring strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir\u002Fritonavir, indinavir, itraconazole, ketoconazole, lopinavir\u002Fritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir\u002Fritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine).\n* Presence of any of the following concomitant conditions: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia, severe gastrointestinal diseases, or genetic disorders such as galactose intolerance.\n* Hypersensitivity to colchicine treatment.\n* Currently taking colchicine for another condition.\n* Requiring anticoagulant therapy.\n* Liver disease classified as Child-Pugh class B or C.\n* Renal disease with creatinine clearance \\\u003C30 mL\u002Fmin.\n* Pregnant, breastfeeding, or women of childbearing age.\n* Currently has a malignancy or has a history of malignancy within the past 5 years.\n* Life expectancy of less than 5 years.\n* Contraindication for ticagrelor use (history of intracranial hemorrhage, active pathological bleeding, or liver disease classified as Child-Pugh class B or C).\n* Patients receiving regular administration of systemic steroids, immunosuppressants, or biological agents (e.g., TNF-alpha inhibitors)\n* Patients with active infectious diseases","90 Years",{"count":560,"type":22},490,[25],"The previous Mono Antiplatelet and Colchicine Therapy (MACT) pilot study (NCT04949516) demonstrated that it was feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after percutaneous coronary intervention (PCI) in addition to potent P2Y12 inhibitors in patients with acute coronary syndrome (ACS). However, the efficacy and safety of MACT have not yet been investigated. The goal of this clinical trial is to evaluate the clinical outcomes of ticagrelor P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS. The main questions it aims to answer are:\n\n* What is the frequency of the composite endpoint of cardiovascular death, nonfatal spontaneous myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding at 12 months post-intervention?\n* What is the frequency of stent thrombosis at 12 months post-intervention?\n\nFor pre-specified analyses, researchers will compare MACT to less than 1 month, 3-month, and 12-month dual antiplatelet therapy (individual patient data from the T-PASS \\[NCT03797651\\] and TICO \\[NCT02494895\\] trials) to determine if MACT is effective in treating ACS.\n\nParticipants will:\n\n* Take low-dose colchicine in addition to ticagrelor maintenance therapy, discontinuing aspirin the day after PCI.\n* Take a high-sensitivity C-reactive protein (hs-CRP) test 1 month after PCI.\n* Discontinue colchicine if the hs-CRP level is less than 2 mg\u002FL, or continue colchicine if it is not.\n* Visit the clinic for check-ups at 1, 3, 6, 9, and 12 months after PCI.",[30],[565],"Colchicine","2026-02-15",{"date":568,"type":48},"2026-02-18",{"date":570,"type":48},"2024-08-05",{"date":572,"type":22},"2028-12",{"name":574,"class":55},"CHA University",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":4,"enrollmentInfo":583,"targetDuration":281,"studyType":68,"phases":4,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":92},"100604627","thrombus-aspiration-and-pathology-and-oct-study-100604627","NCT07151976","Thrombus Aspiration and Pathology and OCT Study","Pathologic Features of Aspirated Athero-Thrombotic Material From OCT-Verified Culprit Lesion in Acute Coronary Syndrome (TAPOS)","TAPOS","Inclusion Criteria:\n\n1. Patients with ACS showing ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) are studied.\n2. Only native coronary artery lesions are included in the study.\n3. Optical coherence tomography (OCT) was performed prospectively to compare OCT culprit lesions characteristics with histological analysis of athero-thrombotic aspirated material of the culprit lesion. For this purpose, only lesions with both athero-thrombotic aspirated material and OCT observations are included in the study.\n4. All patients provided written informed consent for the index procedure, follow-up, and anonymous data management.\n\nExclusion Criteria:\n\n1. Patients are excluded from the study when they had cardiogenic shock and contraindications to anticoagulation and anti-platelet therapy.\n2. Lesions located in tortuous vessels, in ostial segment and in the left main stem are excluded from the study due to the difficulty in performing high-quality intracoronary imaging.",{"count":584,"type":22},200,"Most acute coronary syndromes (ACS) are caused by plaque complications triggering thrombotic events in the culprit plaques. Plaque complications include plaque rupture (Ruptured Fibrous Cap-RFC) with exposure of highly thrombogenic substrate to the flow and plaque erosion (Intact Fibrous Cap-IFC) a condition characterized by endothelial\u002Fintimal damage occurring over non-ruptured plaques. Far less commonly (\\\u003C5%), calcified nodules (CN) may trigger acute coronary thrombosis. Plaque rupture accounts for 75% of fatal AMI in autopsy series, while erosion is found in about 25% of cases. These proportions have been supported by in vivo invasive studies (OCT) and OCT-pathology correlation studies. However, it remains unclear whether OCT findings consistently align with in vivo pathology-based evidence of RFC in ACS. Guidelines addressing treatments of ACS unanimously indicate percutaneous coronary intervention (PCI) to restore the coronary flow. Pre-PCI thrombus aspiration is not currently indicated by most guidelines, with the exception of cases with very high thrombus burden. The samples retrieved from thrombus aspiration can be suitable for pathology investigation and aim to evaluate the presence of plaque components in the context of the thrombotic material, a finding that demonstrates plaque rupture as the substrate for the acute coronary event. These studies are uniquely qualified to provide information on the correct OCT-based interpretation of plaque complications in ACS and require OCT imaging quality suitable to classify RFC, IFC, and CN.\n\nTherefore, a prospective OCT-pathology study was designed using the pre-PCI aspirated material from patients with high thrombus burden, to explore the contribution of pathology study in OCT-based classification of plaque complications.",[30],"2026-02-03",{"date":589,"type":48},"2026-02-05",{"date":591,"type":48},"2016-07-01",{"date":593,"type":22},"2027-12-31",{"name":595,"class":55},"Fujita Health University",{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":293,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":619,"locationsCount":92},"100623032","dapt-strategy-in-hbr-patients-undergoing-complex-pci-following-acs-second-phase-beta-testing-of-a-patients-decision-aid-100623032","NCT07391358","DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid","Dual Antiplatelet Therapy Strategy in High Bleeding Risk Patients Undergoing Complex Percutaneous Coronary Intervention Following Acute Coronary Syndrome: Second-Phase Beta Testing of a Patients Decision Aid","BETA-DAPT","Inclusion Criteria (Patients)\n\n* Adults aged 18 years or older\n* Hospitalized on the coronary care unit ward at the Montreal Heart Institute (MHI)\n* Acute coronary syndrome (ACS) during the current episode of care, treated with PCI and placement of one or more coronary stents\n* High bleeding risk based on PRECISE-HBR score and high thrombotic risk, with both risks considered of comparable clinical importance by the treating medical team\n\nInclusion Criteria (Clinicians)\n\n\\- Clinicians working in the MHI coronary care unit (cardiologists, medical residents, nurse practitioners, or pharmacists) who use the patient decision aid with one or more study participants\n\nExclusion Criteria (Patients)\n\n* Receiving therapeutic anticoagulation\n* Planned cardiac surgery during the same episode of care\n* Prior history of coronary stent thrombosis\n* Antiphospholipid syndrome or known thrombophilia\n* Unable to participate in shared decision-making\n* Unable to understand spoken and written French or English\n* Concurrent participation in another study (followed within another research protocol)\n* Transferred from another center for reasons other than coronary angiography at MHI and expected to return to the referring center for ongoing care (i.e., \"fly-in\u002Ffly-out\" patients)",{"count":605,"type":22},26,[159],"Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at high thrombotic risk. In this population, several dual antiplatelet therapy (DAPT) strategies may be considered: (1) de-escalation of DAPT intensity after 1 to 3 months (switch from ticagrelor\u002Fprasugrel to clopidogrel), (2) shortening DAPT duration to 1 to 3 months followed by antiplatelet monotherapy, (3) 12-month clopidogrel-based DAPT, and (4) 12-month ticagrelor\u002Fprasugrel-based DAPT. Selecting the most appropriate DAPT strategy in this dual-risk context is complex, and clinical trial evidence is limited for this specific subgroup. In the absence of clear guideline recommendations to support decision-making for patients facing both elevated bleeding and thrombotic risks, structured shared decision-making support is needed.\n\nIn this context, within research project 2025-3499 conducted with pharmacy residents, we developed a patient decision aid (PDA) designed to support shared decision-making by helping patients understand their risks, available options, and potential consequences, so they can express their preferences regarding antiplatelet therapy. The PDA aims to facilitate shared decisions by improving patients' understanding of benefits and harms and aligning choices with patient values. A preliminary version of the tool has already undergone alpha testing with a small group of internal users (physicians, pharmacists, and patient partners). The next step is beta testing, that is, real-world testing with the target population and clinicians to evaluate usability and acceptability in routine practice.",[30],[610,611,612,613],"High bleeding risk","Complex percutaneous coronary intervention","Double antiplatelet therapy","Patient decision aid","2026-01-29",{"date":589,"type":48},{"date":617,"type":22},"2026-02-01",{"date":88,"type":22},{"name":620,"class":55},"Montreal Heart Institute",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"100353578","acute-myocardial-infarction-prognostic-and-therapeutic-evaluation-100353578","NCT03883711","Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation","Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment","AMIPE","Inclusion Criteria:\n\n* Patient aged \\> 18 years old\n* Acute coronary syndrome or myocardial injury\n* Written informed consent\n\nExclusion Criteria:\n\n* under age or not able to give informed consent",{"count":630,"type":22},11000,"AMIPE is both a retrospective and prospective study which was designed in order to collect data of patients with acute coronary syndromes and myocardial injury and to improve the knowledge about these conditions.",[30,633],"Myocardium; Injury",[635,636,79,637],"Acute coronary syndrome","Myocardial injury","MINOCA","2026-01-28",{"date":640,"type":48},"2026-01-30",{"date":642,"type":48},"2017-01-01",{"date":644,"type":22},"2028-12-31",{"name":646,"class":55},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",3,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":155,"enrollmentInfo":656,"targetDuration":658,"studyType":68,"phases":4,"briefSummary":659,"conditions":660,"keywords":663,"overallStatus":293,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":673,"locationsCount":4},"100622126","brevoc-study-exhaled-vocs-for-high-risk-chest-pain-in-the-ed-100622126","NCT07379567","BREVOC Study: Exhaled VOCs for High-Risk Chest Pain in the ED","Application of Rapid Detection of Exhaled Volatile Organic Compounds in the Emergency Department for Differentiating High-Risk Chest Pain Patients","BREVOC","Inclusion Criteria：\n\n* Age between 18 and 80 years, regardless of gender\n* Presenting to the Emergency Department with acute chest pain=\n* Able to provide informed consent\n\nExclusion Criteria：\n\n* Unable to perform breath sampling\n* Incomplete medical records\n* Refusal to participate by the patient or legal representative\n* Presence of any of the following conditions:Recent pulmonary infection、 Primary liver or kidney dysfunction、Chronic respiratory or digestive system diseases、Terminal illness or receiving palliative care\n* Participation in another clinical research study within the past 30 days",{"count":657,"type":22},6000,"1 Year","Study Objectives\n\n1. Screening and identification of diagnostic biomarkers: To establish the exhaled volatile organic compound (VOC) profile of patients with acute high-risk chest pain and to differentiate high-risk chest pain patients.\n2. Exploration of aldehyde detection: To investigate the role of exhaled aldehyde detection in high-risk chest pain patients; to establish and validate an early differential diagnostic model of exhaled VOCs for high-risk chest pain, thereby optimizing emergency triage procedures.\n3. Prognostic evaluation: To assess the predictive value of VOC concentration changes for in-hospital mortality and major adverse cardiovascular events (MACE) in high-risk chest pain patients.\n4. Novel diagnostic markers: To explore new biomarker combinations superior to conventional diagnostic indicators.\n\nStudy Hypotheses\n\n1. High-risk chest pain patients present a VOC profile distinct from that of healthy individuals and patients with other causes of chest pain.\n2. Baseline levels and early changes of exhaled VOCs can achieve both rapid diagnosis and risk stratification.\n3. Exhaled VOCs can predict the prognosis of high-risk chest pain patients. Sample Size Calculation This is an exploratory study, aiming to enroll all patients presenting with acute chest pain to the emergency department of our hospital between May 2025 and June 2026. Based on prior studies, the primary endpoint is assessed using area under the receiver operating characteristic curve (AUC-ROC) analysis, with α = 0.05 and 1-β = 0.90. The expected model AUC is 0.75, compared to a minimum acceptable AUC of 0.65. Assuming a group ratio of 1:2 (high-risk: non-high-risk), Power Analysis and Sample Size (PASS) software estimates a minimum sample size of approximately 1,320 patients.\n\nTo enable subgroup analyses (e.g., acute coronary syndrome \\[ACS\\], pulmonary embolism \\[PE\\], aortic dissection \\[AD\\]) and the construction of multivariable predictive models, at least 150-300 patients per subgroup are required. According to preliminary investigation, the emergency department admits approximately 20 chest pain patients daily. To ensure model stability, cross-validation, and sufficient subgroup evaluation, a total of 6,000 patients will be prospectively enrolled, thereby enhancing scientific rigor and external validity.\n\nPrimary Outcome Discrimination between high-risk and non-high-risk chest pain patients, assessed by AUC-ROC, sensitivity, and specificity.\n\nSecondary Outcomes\n\n1. Missed diagnosis rate (the proportion of high-risk patients misclassified as low or intermediate risk by the model).\n2. Average emergency department length of stay and medical costs under model-guided triage.\n3. In-hospital mortality and incidence of major adverse cardiovascular events (MACE).\n\nStatistical Methods\n\n1. Categorical variables will be expressed as frequencies or percentages; normally or approximately normally distributed continuous variables as mean ± standard deviation; and skewed data as median (P25, P75). Between-group comparisons will be performed using independent-samples t-tests, one-way analysis of variance (ANOVA), Mann-Whitney U tests, or Kruskal-Wallis tests for continuous variables, and chi-square (χ²) tests or Fisher's exact tests for categorical variables.\n2. Feature selection of VOCs will be performed using methods such as least absolute shrinkage and selection operator (LASSO) regression, followed by the construction of a VOC scoring model.\n3. Prognostic factors will be assessed using Cox proportional hazards models.\n4. Trajectory analysis will be applied to evaluate changes in VOC concentrations over time.",[30,661,662],"High-Risk Chest Pain","Volatile Organic Compounds",[635,664,665,168,666,667],"Breath analysis","Volatile organic compounds","Aortic dissection","Pulmonary embolism","2026-01-23",{"date":640,"type":48},{"date":671,"type":22},"2026-03-01",{"date":593,"type":22},{"name":674,"class":55},"Qilu Hospital of Shandong University",{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":681,"eligibilityCriteria":682,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":23,"phases":685,"briefSummary":686,"conditions":687,"keywords":705,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":716,"lastUpdatePostDateStruct":717,"startDateStruct":719,"completionDateStruct":721,"leadSponsor":723,"locationsCount":92},"100557242","single-vs-dual-antiplatelet-therapy-in-elderly-or-hbr-patients-undergoing-percutaneous-intervention-with-dcb-piccoleto-iv-epic-38-100557242","NCT06535568","Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)","International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (PICCOLETO IV-EPIC 38)","PIV-EPIC","Inclusion Criteria:\n\nMale and female patients who meet the following criteria:\n\n* Age ≥ 75 years or age ≥ 18 years at high bleeding risk;\n* Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels;\n* Stable or unstable coronary syndromes;\n* De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation);\n* Informed consent to participate in the study given by the patient or impartial witness.\n\nExclusion Criteria:\n\n* Stent implantation during index or recent (\\\u003C6 months) procedure;\n* Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated;\n* Pregnancy at the time of hospitalization;\n* Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer;\n* ST-elevation myocardial infarction;\n* Life expectancy \\\u003C12 months;\n* Left ventricular ejection fraction \\\u003C30%;\n* Visible thrombus at lesion site;\n* Target lesion\u002Fvessel with any of the following characteristics:\n\n  * severe and\u002For \\>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);\n  * left main stem stenosis \\>50%;\n  * target lesion is in the left main stem;\n  * chronic total occlusion with anticipated necessity of retrograde approach;\n  * lesion is in a bypass graft.\n* History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs);\n* History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;\n* Acute gastrointestinal ulcers;\n* Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin);\n* Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT\u002FAST \\> 2 x ULN or total bilirubin \\>1.5 x ULN);\n* Severe cardiac failure (NYHA grade III or IV);\n* Combination with methotrexate at doses of 15 mg\u002Fweek or more;\n* Patients with baseline neutrophil counts \\\u003C 1500 cells\u002Fmm³;\n* Breastfeeding women;\n* Full-blown thyrotoxicosis;\n* Patients with a very high risk of thrombosis.",{"count":684,"type":22},576,[159],"This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.",[162,163,164,173,688,166,167,28,30,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704],"Atherosclerosis","Coronary Stenosis","Molecular Mechanisms of Pharmacological Action","Enzyme Inhibitors","MTOR Inhibitors","Protein Kinase Inhibitors","Physiological Effects of Drugs","Immunosuppressive Agents","Antineoplastic Agents","High Bleeding Risk","Single Antiplatelet Therapy","Dual Antiplatelet Therapy","Cyclooxygenase Inhibitors","P2Y12 Inhibitor","Platelet Aggregation Inhibitors","Aspirin","Clopidogrel",[706,707,708,709,710,711,712,713,714,715],"DCB","Angioplasty","Paclitaxel","Antiplatelet treatment","Single antiplatelet therapy (SAPT)","Dual antiplatelet therapy (DAPT)","High bleeding risk (HBR)","MACE","Native CAD","stable or unstable coronary syndromes","2026-01-21",{"date":718,"type":48},"2026-01-22",{"date":720,"type":48},"2026-01-10",{"date":722,"type":22},"2028-02-20",{"name":724,"class":55},"Fondazione Ricerca e Innovazione Cardiovascolare ETS",{"id":726,"slug":727,"hasResults":12,"nctId":728,"briefTitle":729,"officialTitle":730,"acronym":731,"eligibilityCriteria":732,"healthyVolunteers":12,"sex":18,"minAge":65,"maxAge":4,"enrollmentInfo":733,"targetDuration":4,"studyType":23,"phases":734,"briefSummary":736,"conditions":737,"keywords":738,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":740,"lastUpdatePostDateStruct":741,"startDateStruct":743,"completionDateStruct":745,"leadSponsor":747,"locationsCount":92},"100595433","phase-2-a-polypill-for-acute-coronary-syndrome-100595433","NCT07032389","A Polypill for Acute Coronary Syndrome","Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial","PolyACS","Inclusion Criteria:\n\n* Age ≥ 18\n* Hospitalization for acute coronary syndrome with percutaneous coronary intervention\n* Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin\n\nExclusion Criteria:\n\n* Current need for systemic anticoagulation\n* Contraindication to receive any components of the polypill\n* History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin\n* Comorbidities that might be expected to limit lifespan within the 12-month study period\n* Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \\\u003C 12 months\n* Inability to provide written informed consent\n* Pregnancy",{"count":528,"type":22},[735],"PHASE2","The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.",[30],[30,739,453],"Polypill","2026-01-16",{"date":742,"type":48},"2026-01-20",{"date":744,"type":48},"2025-12-05",{"date":746,"type":22},"2029-08-01",{"name":748,"class":55},"University of Texas Southwestern Medical Center"]