[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517090":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":66,"collaborators":41,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":41,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":41,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Zunyi Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Guided NOAC and DAPT","EXPERIMENTAL","The first month: rivaroxaban 2.5 mg twice daily (if CR≥24) plus standard DAPT (ticagrelor 90 mg twice daily or clopidogrel 75 mg daily plus aspirin 100 mg daily).\n\nThe following 11 months: lower-dose ticagrelor 60 mg twice daily (45 mg twice daily if \\\u003C50 kg, ≥75 yrs) or clopidogrel (75 mg daily) plus aspirin (100 mg daily).",[13],"Drug: NOAC+DAPT",{"label":15,"type":10,"description":16,"interventionNames":17},"Unguided DAPT","The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.",[18],"Drug: DAPT",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","NOAC+DAPT","Century Clot-guided rivaroxaban plus DAPT.",[9],[26],"Rivaroxaban + ticagrelor or clopidogrel + aspirin",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DAPT","Standard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.",[15],[32],"Ticagrelor or clopidogrel + aspirin",[34],{"name":35,"affiliation":5,"role":36},"Cai De Jin, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","86+178-0250-2582",null,"jincaide@zmu.edu.cn",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Yan Yan Jin, MD","86+157-7229-0925","jinyanyan850925@163.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Affiliated Hospital of Zunyi Medical University","RECRUITING","Zunyi","Guizhou","563003","China","CN",{"type":57,"coordinates":58},"Point",[59,60],106.90722,27.68667,{"lat":60,"lon":59},[63,64,65],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},{"name":35,"role":36,"phone":41,"phoneExt":41,"email":41},{"type":36,"investigatorFullName":35,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Principal Investigator","100517090","phase-4-century-clot-guided-prophylactic-rivaroxaban-for-post-stemi-complicating-left-ventricular-thrombus-100517090",false,"NCT06013020","Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus","Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy","Inclusion Criteria:\n\n* Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv) ST-segment elevation in anterior leads on a standard 12-lead electrocardiogram.\n* Patients provide written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Intracranial, gastrointestinal, or urogenital bleeding within 6 months\n* Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism);\n* Bleeding diathesis, thrombocytopenia (platelet \\\u003C100,000\u002FmL) or hemoglobin \\\u003C10 g\u002FdL, and CRUSADE score-based high bleeding risk\n* Hepatic dysfunction (serum liver enzyme\\>3 times the normal limit)\n* Renal failure (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2 or requiring dialysis)\n* Severe chronic obstructive pulmonary disease\n* Severe bradycardia (sick sinus syndrome or high degree atrioventricular block without pacemaker protection)\n* Drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin\n* Life expectancy \\\u003C 1 year","ALL","18 Years","75 Years",{"count":79,"type":80},374,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture, triggers platelet activation\u002Faggregation and thrombin generation, requires dual (platelet and coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge, since that increase in potential risk of bleeding.\n\nAlthough the incidence of left ventricular thrombus (LVT) formation after STEMI decreased in modern reperfusion therapy, including primary percutaneous coronary intervention (PCI), remains at 4% to 26%, especially that complicated by anterior STEMI. The recommendation of an OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited. How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile, and prevent LVT formation is challenging, since insufficient evidence is available from randomized trials.\n\nCentury Clot analyzer is point-of-care testing that could assess the coagulate state: normal, hypo-coagulable, or hyper-coagulable states according to clot rate (CR) value. Whether Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT formation without increasing major bleeding is uncertain.",[86],"STEMI - ST Elevation Myocardial Infarction",[88],"Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI","2024-03-16",{"date":91,"type":92},"2024-03-19","ACTUAL",{"date":94,"type":80},"2024-04-01",{"date":96,"type":80},"2027-12-31",{"name":5,"class":6},1]