[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nstemi---non-st-segment-elevation-myocardial-infarction-mi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nstemi---non-st-segment-elevation-myocardial-infarction-mi":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,90,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100570664","phase-4-treatment-with-aspirin-alone-versus-aspirin-in-combination-with-fondaparinux-before-early-coronary-assessment-in-patients-with-non-st-elevation-myocardial-infarction-100570664",false,"NCT06710184","Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction","Aspirin Versus Aspirin and Fondaparinux Prior to Early Invasive Strategy in Patients With NSTEMI","FOXY","Inclusion Criteria:\n\n* Diagnosis of NSTEMI verified by:\n\n  * Rise or\u002Fand fall in cardiac troponin (cTN) and\n  * Symptoms of acute ischemia or ECG-changes compatible with acute ischemia.\n* Age above 18 years old\n* Expected remaining lifespan above 1 year\n* Informed consent\n\nExclusion Criteria:\n\n* Treatment with any anticoagulants before enrollment and randomization\n\n  * Including any direct anticoagulant (DOAC), LMWH, UFH or warfarin.\n* Not possible with CAG and PCI within 72 hours\n* Unsuitable for CAG and possible PCI due to poor condition\n* Estimated glomerular filtration rate (eGFR) \\\u003C 20 ml\u002Fmin\u002F1.73m2\n* Known liver disease\n* Active bleeding or high risk of bleeding where treatment with Fondaparinux is contraindicated.\n* Anemia (B-Hemoglobin \\\u003C 6.0 mmol\u002Fl)\n* Pregnancy or breastfeeding\n* Endocarditis\n* Indication for acute CAG before enrollment and randomization:\n\n  * ST-elevation Myocardial Infarction (STEMI)\n  * Patients classified as \"Very High Risk\" according to ESC guidelines, defined as(1):\n\n    * Hemodynamic instability (in need of inotropic support) or cardiogenic shock (DANGER-SHOCK criteria (20)) at time of admission.\n    * Acute heart failure because of presumed acute ischemia\n    * Life-threatening arrhythmias or cardiac arrest\n    * Mechanical complications (such as papillary muscle rupture with acute mitral regurgitation, free wall rupture and interventricular rupture)","ALL","18 Years",{"count":20,"type":21},5076,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The main goal of this study is to compare two treatments in patients with a specific type of heart attack called Non-ST-elevation Myocardial Infarction (NSTEMI). The investigators want to find out whether using aspirin alone is as effective and safer than using aspirin together with a second blood thinner called fondaparinux.\n\nBoth treatments will be given before a scheduled heart procedure called coronary angiography (CAG), which may include balloon dilation and stent placement (PCI) if needed.\n\nThe current guidelines recommend using aspirin in combination with a second blood thinner like fondaparinux before CAG and possible PCI. However, these recommendations are based on studies from the 1990s, a time when invasive procedures were not standard practice for these patients. In contrast, nearly all patients with NSTEMI in Denmark (96%) now undergo CAG within 72 hours. This change in practice raises questions about whether the older studies still provide a valid foundation for today's guidelines.\n\nThe study aims to answer two questions:\n\n1. Is aspirin alone as effective as aspirin combined with fondaparinux before early CAG and possible PCI?\n2. Is aspirin alone safer, with a lower risk of severe bleeding, compared to the combination treatment?\n\nTo answer these questions, the investigators will enroll about 5,000 patients with NSTEMI. Participants will be randomly assigned to receive either aspirin alone or aspirin with fondaparinux. The investigators will monitor them for 30 days to compare outcomes such as death, new heart attacks, the need for urgent CAG before the scheduled, and severe bleeding.",[27,28],"NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)","Acute Myocardial Infarction (AMI)",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Acute Myocardial Infarction","Non-ST Segment Elevation Myocardial Infarction","Aspirin","Fondaparinux","Anticoagulation","Coronary Angiography","Percutaneus Coronary Intervention","Acute Coronay Syndrome","Early Invasive Treatment","Refractory ischemia","Bleeding risk","Mortality","Randomized Controlled Trial","New Myocardial Infarction","Non-inferiority Trial","Multicenter Study","Antithrombotic","RECRUITING","2026-04-28",{"date":50,"type":51},"2026-05-04","ACTUAL",{"date":53,"type":51},"2025-05-01",{"date":55,"type":21},"2029-07-01",{"name":57,"class":58},"University of Aarhus","OTHER",10,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100632251","phase-4-multicenter-trial-of-antithrombotic-strategies-in-acute-coronary-syndrome-with-coronary-artery-ectasia-100632251","NCT07511257","Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia","Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: A Multicenter Randomized Clinical Trial","OVER-TIME II","Inclusion Criteria:\n\n* Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation.\n* Recent ACS within 7 days prior to enrollment, defined by all of the following:\n* Clinical presentation consistent with acute coronary syndrome.\n* Elevated high-sensitivity cardiac troponin above the 99th percentile.\n* Presence or absence of persistent ST-segment elevation.\n* Coronary artery ectasia in the culprit coronary artery, defined by all of the following:\n* The presence of ectasia will be determined by agreement of two expert interventional cardiologists, and will be confirmed by quantitative coronary angiography (QCA).\n* Identification of a culprit artery consistent with the electrocardiographic territory involved (in cases with ST-segment elevation) or with angiographic features suggestive of an atherothrombotic event, such as the presence of thrombus or reduced coronary flow.\n* Hospital admission lasting more than 24 hours.\n* Management with either percutaneous coronary intervention or medical therapy, as determined by the treating medical team. Intracoronary interventions such as stent implantation, balloon angioplasty, or thrombus aspiration are permitted.\n* Ability and willingness to provide written informed consent and to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Current indication for temporary or long-term anticoagulation therapy at the time of enrollment.\n* Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² at hospital discharge.\n* History of major bleeding, active bleeding, or high bleeding risk, including but not limited to gastrointestinal bleeding, intracranial hemorrhage, or other conditions considered by the treating physician to confer a high risk of bleeding.\n* Advanced heart failure, defined as left ventricular ejection fraction (LVEF) \\\u003C30% plus at least one of the following:\n* More than two hospitalizations or unplanned emergency department visits for heart failure in the past year, or\n* NYHA functional class III or IV symptoms despite optimal medical therapy at enrollment or within the previous 3 months.","80 Years",{"count":70,"type":21},326,[24],"Coronary artery ectasia (CAE) is a condition in which a coronary artery becomes abnormally dilated, measuring at least 50% larger than the adjacent normal segment. Although relatively uncommon, CAE is clinically important because it can lead to abnormal blood flow and increase the risk of blood clot formation. Patients with CAE are at higher risk of angina, myocardial infarction, and complications during coronary interventions. Despite these risks, the optimal antithrombotic treatment for patients with acute coronary syndrome (ACS) and CAE remains uncertain.\n\nDual antiplatelet therapy (aspirin plus clopidogrel) is currently the most commonly used treatment. However, the abnormal blood flow patterns observed in CAE may promote clot formation through mechanisms that could potentially be better addressed with anticoagulant therapy.\n\nThe OVER-TIME II trial is a multicenter randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and CAE: standard dual antiplatelet therapy versus antiplatelet monotherapy combined with anticoagulation. The study aims to determine whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.",[74,75,76,27],"Coronary Artery Ectasia","Acute Coronary Syndromes (ACS)","STEMI - ST Elevation Myocardial Infarction",[74,78,34,79],"Acute Coronary Syndrome","Dual Antiplatelet Therapy","2026-04-06",{"date":82,"type":51},"2026-04-09",{"date":84,"type":51},"2026-02-11",{"date":86,"type":21},"2029-06",{"name":88,"class":58},"Instituto Nacional de Cardiologia Ignacio Chavez",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":108,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":89},"100627155","safety-and-effectiveness-of-the-crystalline-sirolimus-eluting-device-in-patients-with-coronary-artery-disease-100627155","NCT07444957","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device in Patients With Coronary Artery Disease","Safety and Effectiveness of the Crystalline Sirolimus-Eluting Device (SeQuent® Sirolimus-Coated Balloon) in Patients With Coronary Artery Disease: A Prospective Observational Study","SECuRE","Inclusion Criteria:\n\n* All patients must provide written informed consent.\n* Patients aged ≥18 years with coronary artery disease in whom, at the operator's discretion, treatment of a coronary stenosis in a native vessel (either de novo lesion or in-stent restenosis) or in a coronary bypass graft using the cSCB is indicated, in accordance with routine clinical practice.\n* All treated lesions\u002Fsegments (single or tandem) must receive cSCB therapy covering at least 3 mm beyond both edges of the lesion or pre-dilated segment to avoid geographic miss.\n* In patients with multivessel coronary artery disease, all non-target vessels will be treated according to operator discretion: a) If more than one vessel is treated with the investigational device (SeQuent® SCB), all vessels will be documented and analyzed separately. b) Only one lesion per vessel will be included unless lesions are separated by ≥20 mm. c) Only one lesion per vessel will be included. d) If more than one lesion in the target vessel requires treatment, all lesions treated with a device different from the investigational procedure or with a device other than the investigational device (SeQuent® SCB) must be separated from the target lesion by ≥20 mm or considered as a single treated lesion according to this study protocol.\n\nExclusion Criteria:\n\n* Explicit refusal by the patient to participate in the study.\n* Known intolerance to sirolimus or to any component of the investigational device.\n* Contraindication to any antiplatelet therapy.\n* Life expectancy less than 12 months.\n* Indication for surgical coronary revascularization.\n* Pregnancy or breastfeeding.\n* Clinical characteristics considered unsuitable for drug-coated balloon use at the operator's discretion, including: a) Hemorrhagic diathesis or other conditions such as gastrointestinal ulceration or cerebrovascular disorders restricting the use of antiplatelet therapy. b) Cardiogenic shock. c) Patients with left ventricular ejection fraction \\\u003C30% without the use of a ventricular assist device during PCI.\n\nAngiographic exclusion criteria\n\n* Reference vessel diameter \\\u003C2.00 mm or \\>4.0 mm.\n* Treatment of the left main coronary artery.\n* Lesions not amenable to PCI or other interventional techniques.\n* Coronary artery spasm in the absence of significant stenosis.\n* Target lesion not suitable for drug-coated balloon-only PCI at the operator's discretion, including: a) Aorto-ostial lesions. b) Lesions with significant persistent residual thrombotic content visible in the vessel despite thromboaspiration. c) Treatment shortly after myocardial infarction with evidence of thrombus or impaired coronary flow.",{"count":99,"type":21},1118,"OBSERVATIONAL","This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled.\n\nThe primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups.\n\nThe study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.",[103,27,104,105,106,107],"Coronary Arterial Disease (CAD)","Stable Angina, Unstable Angina, NSTEMI","Drug Coated Balloon","ST-Elevation Myocardial Infarction","Silent Ischemia",[109,110,111,112,113],"coronary arterial disease","drug coated ballloon","TLR","TVR","MACE","2026-03-02",{"date":116,"type":51},"2026-03-03",{"date":118,"type":51},"2026-01-05",{"date":120,"type":21},"2030-07-06",{"name":122,"class":58},"Fundación Interhospitalaria para la Investigación Cardiovascular FIC",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100615291","phase-4-intensive-cholesterol-lowering-within-24-hours-of-pci-perioperative-period-100615291","NCT07290699","Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period","INtensive Cholesterol-Lowering With recatIcimab combiNation in Emergency PCI for Acute Myocardial Infarction: A Randomized Controlled Trial","INCLINE-AMI","Inclusion Criteria:\n\n* Age ≥18 years;\n* Meet the definition of acute myocardial infarction according to the \"2019 Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction\", including STEMI and NSTEMI with onset \\\u003C24 hours;\n* Able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Severe mental disorders that prevent the expression of consent;\n* Severe heart failure (Killip class III or IV) or cardiogenic shock;\n* According to the investigator's judgment, the presence of significant other abnormal signs, laboratory findings, or clinical conditions (such as tumors, shock, liver or kidney failure, etc.) that make participation unsuitable;\n* Investigator's judgment that the subject cannot complete long-term follow-up;\n* Intolerance to statins or cholesterol absorption inhibitors;\n* Intolerance to injections;\n* Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization;\n* Pregnant women.",{"count":132,"type":21},2442,[24],"This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included \\\u003C24h STEMI and NSTEMI), and subsequently once every 12 weeks for a total of 6 months, followed by step-down therapy according to guideline-recommended lipid-lowering strategies based on LDL-C target levels. The study will evaluate changes in blood lipids and inflammatory markers during hospitalization and at follow-up visits at 1, 3, 6, 9, and 12 months, as well as the incidence of MACE events. Safety will also be assessed, including liver enzymes, kidney function, and other adverse reactions. Compared with conventional treatment, the study will test efficacy and ultimately clarify that early combined use of PCSK9 inhibitors during the perioperative period of AMI patients can safely and effectively reduce LDL-C, control systemic inflammatory responses, and improve the incidence of MACE events.",[76,27],[137,138,139],"Acute myocardial infarction","Recaticimab","PCSK9 inhibitor","NOT_YET_RECRUITING","2025-12-16",{"date":143,"type":51},"2025-12-18",{"date":145,"type":21},"2026-01-01",{"date":147,"type":21},"2028-08-30",{"name":149,"class":58},"Second Affiliated Hospital of Nanchang University"]