[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626140":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":78,"collaborators":25,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":25,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspirin","EXPERIMENTAL","Antiplatelet Agent",[13],"Drug: Aspirin",{"label":15,"type":16,"description":17,"interventionNames":18},"warfarin","ACTIVE_COMPARATOR","Vitamin K antagonist",[19],"Drug: Vitamin K antagonist(warfarin)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","100mg 1 tablet once daily for 6 months",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Vitamin K antagonist(warfarin)","Maintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months",[15],[31],{"name":32,"affiliation":33,"role":34},"Joon-Bum KIM, MD","jbkim1975@amc.seoul.kr","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":33},"Joon-bum Kim, MD","CONTACT","82230105416",[41,57,66],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"National Cerebral and Cardiovascular Center Hospital","NOT_YET_RECRUITING","Osaka","564-8565","Japan","JP",{"type":49,"coordinates":50},"Point",[51,52],135.50107,34.69379,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":25,"phoneExt":25,"email":25},"Fukushima Satsuki, MD",{"facility":58,"status":43,"city":44,"state":25,"zip":59,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Osaka University Hospital","565-0871",{"type":49,"coordinates":61},[51,52],{"lat":52,"lon":51},[64],{"name":65,"role":38,"phone":25,"phoneExt":25,"email":25},"Yajima Shin, MD",{"facility":5,"status":67,"city":68,"state":25,"zip":69,"country":70,"countryCode":25,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"RECRUITING","Seoul","05505","South Korea",{"type":49,"coordinates":72},[73,74],126.9784,37.566,{"lat":74,"lon":73},[77],{"name":32,"role":38,"phone":25,"phoneExt":25,"email":25},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Joon Bum Kim","Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine","100626140","phase-4-comparison-of-anti-thrombotic-treatments-between-aspirin-and-warfarin-during-initial-six-months-after-bioprosthetic-heart-valve-replacement-100626140",false,"NCT07431762","Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement","CONCLAVE","Inclusion Criteria:\n\n1. Aged ≥ 19 years with successful surgical bioprosthetic valve replacement\n2. Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively\n3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board\u002FEthical Committee of the respective clinical site.\n\nExclusion Criteria:\n\n1. Mechanical valve in any heart valve position\n2. Previous hemorrhagic stroke within the last 3 months\n3. Clinically overt stroke within the last 3 months\n4. Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis)\n5. Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamic support, disabling complications, stroke \\[ischemic, embolic\\], hemorrhagic stroke)\n6. Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist\n7. Pregnant or lactating women","ALL","19 Years",{"count":92,"type":93},1058,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","This trial is a multinational, multicenter, randomized, open-label, active-controlled clinical trial comparing the safety of aspirin versus vitamin K antagonists (warfarin) as oral antithrombotic therapy during the initial 6 months following tissue valve replacement (aortic or mitral).",[99],"Valve Replacement Surgery",[101],"aspirin versus vitamin K antagonists","2026-07-02",{"date":104,"type":105},"2026-07-06","ACTUAL",{"date":107,"type":105},"2026-06-05",{"date":109,"type":93},"2031-03-31",{"name":5,"class":6},3]