[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-bleeding-risk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-bleeding-risk":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,101,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100622402","phase-4-bivalirudin-versus-heparin-during-pci-in-high-bleeding-risk-patients-with-acute-coronary-syndromes-100622402",false,"NCT07383155","Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes","BRIGHT-HBR","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical evidence of NSTE-ACS or recent stabilized STEMI (≥48 hours after symptom onset) undergoing PCI\n* The patient meets the ARC criteria for HBR (≥1 major criterion or ≥2 minor criteria)\n* The patient or legal representative has been fully informed and written informed consent has been obtained\n\nExclusion Criteria:\n\n* STEMI patients within 48 hours of symptom onset\n* CABG or PCI within the prior 6 months, including for the present clinical syndrome\n* Cardiogenic shock\n* Coronary artery disease unsuitable for revascularization or requiring CABG\n* Confirmed or suspected aortic dissection\n* Treatment with a glycoprotein IIb\u002FIIIa inhibitor within 2 hours prior to the PCI (use of intravenous heparin prior to or at the time of randomization is acceptable)\n* Allergy to UFH, bivalirudin, aspirin, clopidogrel, ticagrelor, or contrast agents that cannot be adequately pre-medicated, or any prior anaphylaxis to these agents\n* Any non-cardiac conditions with an expected life expectancy of ≤12 months\n* Patients deemed by the investigator to be clinically unsuitable for coronary angiography and PCI, or who are unlikely to be able to comply with the protocol requirements, including medication adherence and follow-up visits","ALL","18 Years",{"count":19,"type":20},5270,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","Background. Randomized data on the optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) are lacking.\n\nMethods. BRIGHT-HBR is an investigator-sponsored, open-label, randomized controlled trial comparing bivalirudin vs. unfractionated heparin (UFH) monotherapy in HBR patients with ACS undergoing PCI. A total of 5270 HBR patients with a non-ST-elevation acute coronary syndrome (NSTE-ACS) or recent stabilized ST-segment elevation myocardial infarction (STEMI, ≥48 hours after symptom onset) will be randomized 1:1 to bivalirudin or UFH at 70 sites in China. HBR is defined by the Academic Research Consortium (ARC)-HBR criteria. The primary composite endpoint is net adverse clinical events (NACE) at 30 days, the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or BARC types 2, 3 or 5 bleeding, and the major secondary endpoint is BARC types 2, 3 or 5 bleeding. The study is powered to demonstrate that bivalirudin is superior to UFH monotherapy for NACE in ACS patients with HRB at 30 days after PCI.\n\nConclusions. The BRIGHT-HBR randomized trial aims to provide evidence on whether bivalirudin reduces the incidence of NACE and clinically relevant bleeding compared with UFH monotherapy in patients with ACS who are at HBR undergoing PCI.",[26,27,28,29],"Percutaneous Coronary Intervention","High Bleeding Risk","Acute Coronary Syndromes","Anticoagulant Therapy","NOT_YET_RECRUITING","2026-02-01",{"date":33,"type":34},"2026-02-03","ACTUAL",{"date":31,"type":20},{"date":37,"type":20},"2028-12-31",{"name":39,"class":40},"Shenyang Northern Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":79,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"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":50,"type":20},576,[52],"NA","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.",[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,27,72,73,74,75,76,77,78],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Myocardial Ischemia","Atherosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Coronary Artery Disease","Acute Coronary Syndrome","Coronary Stenosis","Molecular Mechanisms of Pharmacological Action","Enzyme Inhibitors","MTOR Inhibitors","Protein Kinase Inhibitors","Physiological Effects of Drugs","Immunosuppressive Agents","Antineoplastic Agents","Single Antiplatelet Therapy","Dual Antiplatelet Therapy","Cyclooxygenase Inhibitors","P2Y12 Inhibitor","Platelet Aggregation Inhibitors","Aspirin","Clopidogrel",[80,81,82,83,84,85,86,87,88,89],"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","RECRUITING","2026-01-21",{"date":93,"type":34},"2026-01-22",{"date":95,"type":34},"2026-01-10",{"date":97,"type":20},"2028-02-20",{"name":99,"class":40},"Fondazione Ricerca e Innovazione Cardiovascolare ETS",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100602584","phase-4-non-antithrombotic-versus-single-antiplatelet-therapy-following-left-atrial-appendage-closure-100602584","NCT07125417","Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure","Non-Antithrombotic Versus. Single antiPlatelet Therapy Following Left Atrial Appendage Closure：NAPT-LAAC Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patient has documented non-valvular atrial fibrillation (i.e, atrial fibrillation without severe mitral stenosis or mechanical valves)\n2. Patient has CHA2DS2-VA score of 2 or greater\n3. Patient meets the guidelines for proper use of the left atrial appendage closure system including patient who has an increased risk of bleeding.\n4. Individual with nonvalvular atrial fibrillation who underwent successful LAAC (defined as no significant residual circumferential leak \\[\\>3 mm\\] or major morbidity by the time of procedure completion).\n5. Patient suitable for pharmacotherapy as defined in this study protocol in both NAPT and SAPT arms\n6. LAA anatomy is accommodate Boston Scientific WATCHMAN FLX Pro and LAAC procedure\n7. The patient and the investigator and\u002For subinvestigator agree that the patient will return for all required VISITs after LAAC procedure\n8. Patient has thoroughly understood the purpose of the study and has provided written informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Patients who are currently enrolled in other clinical trials, except when the patient is participating in a mandatory governmental registries or purely observational registries with no associated treatment.\n2. Individuals require long-term anticoagulation therapy for reasons other than atrial fibrillation (AF)-related stroke risk reduction (e.g.,thrombophilic conditions, previous pulmonary embolism, or deep venous thrombosis).\n3. Patients requiring oral antiplatelet therapy for reasons other than LAAC (e.g.,history of myocardial infarction, history of endovascular treatment, history of stroke\u002Ftransient ischemic attack, significant coronary stenosis proven by myocardial ischemia, severe carotid stenosis requiring invasive treatment,hematologic disease such as antiphospholipid syndrome or if the investigator and\u002For subinvestigator judged the need for antiplatelet therapy).\n4. Patients who meet one or more of the following criteria\n\n   * Patients who are contraindicated for DOAC or VKA\n   * Patients with a contraindication to aspirin\n   * Patients diagnosed with an allergy to aspirin\n5. Those who have or are scheduled to undergo cardiac or noncardiac intervention or surgery 45 days or 60 days before or after LAAC (e.g.,cardioversion, PCI, cardiac ablation, cataract surgery, other structural heart interventions).\n6. Patients with stroke (either ischemic or hemorrhagic) or transient ischemic attack within 30 days prior to enrollment\n7. Patients with active bleeding\n8. Individuals who lack LAA or whose LAA has been surgically ligated\n9. Individuals who experienced a myocardial infarction (with or without intervention) recorded as a non-ST elevation myocardial infarction or ST elevation myocardial infarction in the 30-day period prior to enrollment\n10. Patients with previous atrial septal repair or with atrial septal defect\u002Fpatent foramen ovale device\n11. Patients with mechanical valve prostheses at any site\n12. Persons with known contraindications to TEE\n13. Patients with active infection\n14. Individuals with NYHA class related IV congestive heart failure at enrollment\n15. Patients who are pregnant, breastfeeding, or wishing to become pregnant\n16. Patients with an expected life expectancy of less than 2 years\n17. Patients requiring emergency surgery for any reason\n18. Patients who, at the discretion of the investigator, have other medical, social, or psychological conditions that preclude adherence to appropriate consent or the follow-up tests required by the protocol\n19. Other patients whose investigator or subinvestigator judges their participation in the study to be inappropriate",{"count":109,"type":20},500,[23],"The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet Therapy (SAPT) with aspirin during the period from randomization to the end of observational period (4 years at the maximum) in non-valvular atrial fibrillation subjects with high bleeding risk.\n\nThe primary endpoint is a composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding from randomization to the end of study observation (up to a maximum follow-up of 4 years).\n\n* Participants will be enrolled in this study until the day following the implementation of LAAC and will be randomized to the SAPT arm and NAPT arm in a 1:1 ratio.\n* Participants will be observed for 4 years from the time the first subject is enrolled in this study.\n* Participants will visit the hospital at 45 days, 1 year, and 2 years after enrollment, and will also be followed up by telephone, basically at the end of the observation period (up to a maximum follow-up of 4 years).\n\n\\\u003CStudy treatment duration\\> In both arms, OAC monotherapy will be initiated in the first 24 hours of enrollment and continued for 45 days (allowed window period: plus 2 weeks)..\n\n* SAPT arm will continue to receive 45 days of OAC monotherapy followed by low-dose aspirin (75～100 mg\u002Fday) as an antithrombotic agent required through the end of the study observation period.\n* NAPT arm do not receive antithrombotic medication after 45 days of OAC monotherapy through the end of the study observation period.",[113,77,114,27,115],"Nonvalvular Atrial Fibrillation","Non-Antithrombotic Therapy","Left Atrial Appendage Closure",[115,117,118,77,119],"High bleeding risk","Non-Antithrombotic therapy","Nonvalvular Artial Fibrillation","2025-08-12",{"date":122,"type":34},"2025-08-15",{"date":124,"type":34},"2025-05-29",{"date":126,"type":20},"2030-03-31",{"name":128,"class":40},"OCEAN-SHD Study Group",21,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":138,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":100},"100574781","phase-4-genotype-guided-abbreviated-dapt-versus-un-guided-de-escalation-therapy-in-patients-with-acs-and-hbr-100574781","NCT06763744","Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR","SMart Angioplasty Research Team- Genotype-Guided Abbreviated DUal AntIplatelet Therapy Versus Un-Guided De-escalation Therapy in Patients With Acute Coronary SyndromE and High Bleeding Risk (SMART-GUIDE-HBR)","GUIDE-HBR","Inclusion Criteria:\n\n* Patients must be at least 19 years of age\n* Patients who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.\n* Patients presenting with ACS (ST-elevation myocardial infarction \\[STEMI\\] or non-ST-elevation \\[NSTE\\] ACS).\n* Patients with at least one lesion with equal or greater than 50% diameter stenosis requiring treatment with drug-eluting stents in native coronary artery or graft.\n* Patients with high bleeding risk (by ARC-HBR definition or PRECISE-DAPT score 25 or more)\n\nExclusion Criteria:\n\n* Patients unable to provide consent.\n* Patients who need chronic anti-coagulation therapy.\n* Patients suffering from cardiogenic shock or cardiac arrest\n* Patients with known intolerance to aspirin, all P2Y12 inhibitors, or components of drug-eluting stents.\n* Clinically significant out of range values for platelet count (\\\u003C 50,000\u002Fmm3) or hemoglobin (\\\u003C8 g\u002FdL) at screening\n* Non-cardiac co-morbid conditions are present with life expectancy \\\u003C1 year or that may result in protocol non-compliance (per site investigator's medical judgment).\n* Pregnant or lactating women.","19 Years",{"count":140,"type":20},3000,[23],"The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).",[144,27],"Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)",[146,147,148,149,117],"CYP2C19 Genotype","Acute coronary syndrome","De-escalation therapy","P2Y12 inhibitor monotherapy","2025-05-14",{"date":152,"type":34},"2025-05-18",{"date":154,"type":20},"2025-06-01",{"date":156,"type":20},"2029-12-31",{"name":158,"class":40},"Samsung Medical Center"]