[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100382350":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":223,"collaborators":11,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":229,"sex":235,"minAge":236,"maxAge":11,"enrollmentInfo":237,"targetDuration":11,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Factor Xa inhibitor","EXPERIMENTAL",null,[13],"Drug: Rivaroxaban Oral Tablet",{"label":15,"type":16,"description":11,"interventionNames":17},"Vitamin K antagonist","ACTIVE_COMPARATOR",[18],"Drug: Vitamin K antagonist(warfarin)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Rivaroxaban Oral Tablet","For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\\_creatinine clearance 15-49 mL\u002Fmin, 15mg once daily",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Vitamin K antagonist(warfarin)","For 12months, keep the international normalized ratio (INR) 1.7-3.0",[15],[30],{"name":31,"affiliation":32,"role":33},"Jung-min Ahn, MD","drjmahn@gmail.com","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Jung-hee Ham, RN","CONTACT","82230104728","cvcrc5@amc.seoul.kr",[41,56,68,80,92,104,117,129,138,147,156,166,178,187,199,211],{"facility":42,"status":43,"city":44,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Buchen Sejong Hospital","RECRUITING","Bucheon-si","South Korea",{"type":47,"coordinates":48},"Point",[49,50],126.78306,37.49889,{"lat":50,"lon":49},[53,55],{"name":54,"role":37,"phone":11,"phoneExt":11,"email":11},"Hee-moon Lee, MD",{"name":54,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":57,"status":43,"city":58,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Dong-A University Hospital","Busan",{"type":47,"coordinates":60},[61,62],129.03004,35.10168,{"lat":62,"lon":61},[65,67],{"name":66,"role":37,"phone":11,"phoneExt":11,"email":11},"Yong-rak Cho, MD",{"name":66,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":69,"status":43,"city":70,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Keimyung University Dongsan Hospital","Daegu",{"type":47,"coordinates":72},[73,74],128.59111,35.87028,{"lat":74,"lon":73},[77,79],{"name":78,"role":37,"phone":11,"phoneExt":11,"email":11},"Yoon-suk Kim, MD",{"name":78,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":81,"status":43,"city":82,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"GangNeung Asan Hospital","Gangneung",{"type":47,"coordinates":84},[85,86],128.87239,37.75266,{"lat":86,"lon":85},[89,91],{"name":90,"role":37,"phone":11,"phoneExt":11,"email":11},"Hanbit Park",{"name":90,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":93,"status":43,"city":94,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Chonnam National University Hospital","Gwangju",{"type":47,"coordinates":96},[97,98],126.91556,35.15472,{"lat":98,"lon":97},[101,103],{"name":102,"role":37,"phone":11,"phoneExt":11,"email":11},"Kyo-sun Lee, MD",{"name":102,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":105,"status":43,"city":106,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Seoul National University Bundang Hospital","Seongnam",{"type":47,"coordinates":108},[109,110],127.7548,36.4052,{"lat":110,"lon":109},[113,115],{"name":114,"role":37,"phone":11,"phoneExt":11,"email":11},"Hyung Gon Je, MD",{"name":116,"role":33,"phone":11,"phoneExt":11,"email":11},"Hyung Gon Je",{"facility":5,"status":43,"city":118,"state":11,"zip":119,"country":45,"countryCode":11,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Seoul","138-736",{"type":47,"coordinates":121},[122,123],126.9784,37.566,{"lat":123,"lon":122},[126,128],{"name":127,"role":37,"phone":11,"phoneExt":11,"email":11},"Joon-bum Kim, MD",{"name":127,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":130,"status":43,"city":118,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Korea University Anam Hospital",{"type":47,"coordinates":132},[122,123],{"lat":123,"lon":122},[135,137],{"name":136,"role":37,"phone":11,"phoneExt":11,"email":11},"Ho-Sung Son, MD",{"name":136,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":139,"status":43,"city":118,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Samsung Medical Center",{"type":47,"coordinates":141},[122,123],{"lat":123,"lon":122},[144,146],{"name":145,"role":37,"phone":11,"phoneExt":11,"email":11},"Dong-sub Jung, MD",{"name":145,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":148,"status":43,"city":118,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"Seoul National University Hospital",{"type":47,"coordinates":150},[122,123],{"lat":123,"lon":122},[153,155],{"name":154,"role":37,"phone":11,"phoneExt":11,"email":11},"Jae-woong Choi, MD",{"name":154,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":157,"status":158,"city":118,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"Severance Hospital","NOT_YET_RECRUITING",{"type":47,"coordinates":160},[122,123],{"lat":123,"lon":122},[163,165],{"name":164,"role":37,"phone":11,"phoneExt":11,"email":11},"Gru Hong, MD",{"name":164,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":167,"status":43,"city":168,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Ajou University Hospital","Suwon",{"type":47,"coordinates":170},[171,172],127.00889,37.29111,{"lat":172,"lon":171},[175,177],{"name":176,"role":37,"phone":11,"phoneExt":11,"email":11},"Soo Jin Park, MD",{"name":176,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":179,"status":158,"city":168,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":180,"geoPoint":182,"contacts":183},"St. Vincent's Hospital, Catholic University of Korea",{"type":47,"coordinates":181},[171,172],{"lat":172,"lon":171},[184,186],{"name":185,"role":37,"phone":11,"phoneExt":11,"email":11},"Jin Won Shin, MD",{"name":185,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":188,"status":43,"city":189,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Eulji University Uijeongbu Hospital","Uijeongbu-si",{"type":47,"coordinates":191},[192,193],127.0474,37.7415,{"lat":193,"lon":192},[196,198],{"name":197,"role":37,"phone":11,"phoneExt":11,"email":11},"Joon Lee",{"name":197,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":200,"status":158,"city":201,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Ulsan University Hospital","Ulsan",{"type":47,"coordinates":203},[204,205],129.31667,35.53722,{"lat":205,"lon":204},[208,210],{"name":209,"role":37,"phone":11,"phoneExt":11,"email":11},"Kwan-sik Kim, MD",{"name":209,"role":33,"phone":11,"phoneExt":11,"email":11},{"facility":212,"status":43,"city":213,"state":11,"zip":11,"country":45,"countryCode":11,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Pusan National University Yangsan Hospital","Yangsan",{"type":47,"coordinates":215},[216,217],129.03358,35.34199,{"lat":217,"lon":216},[220,222],{"name":221,"role":37,"phone":11,"phoneExt":11,"email":11},"mi-hee Lim, MD",{"name":221,"role":33,"phone":11,"phoneExt":11,"email":11},{"type":224,"investigatorFullName":225,"investigatorTitle":226,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Joon Bum Kim","Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine","100382350","phase-4-long-term-anticoagulation-with-oral-factor-xa-inhibitor-versus-vitamin-k-antagonist-after-mechanical-aortic-valve-replacement-100382350",false,"NCT04258488","Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement","Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement","RENOVATE","Inclusion Criteria:\n\n1. Age 19 and more\n2. At least 3 months after mechanical aortic valve replacement\n3. At least one of the conditions(as defined below) is met\n\n   * The New York Heart Association (NYHA) Functional Classification I or II; or\n   * According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient \\\u003C20 mm Hg or peak velocity \\\u003C3 m\u002Fs, AND no moderate or severe prosthetic valve regurgitation\n4. Voluntarily participated in the written agreement\n\nExclusion Criteria:\n\n1. Old-generation mechanical valve\n2. History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve\n3. Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis)\n4. Moderate to severe mitral stenosis or regurgitation\n5. History of hemorrhagic stroke\n6. Clinically overt stroke within the last 3 months\n7. Renal failure(creatinine clearance \\\u003C15mL\u002Fmin) or on hemodialysis\n8. Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%\n9. Child-Pugh B and C hepatic impairment or any hepatic disease associated with coagulopathy\n10. Clinically significant active bleeding\n11. Bleeding or hemorrhagic disorder\n12. The increased risk of bleeding due to the following reasons\n\n    1. History of gastrointestinal ulcers or active ulcerations within the last 6 months\n    2. History of intracranial or intracerebral hemorrhage within the last 6 months\n    3. Spinal cord vascular abnormalities or intracerebral vascular abnormalities\n    4. History of the brain, spinal cord, or ophthalmic surgery within the last 6 months\n    5. History of the brain or spinal cord injury within the last 6 months\n    6. History of the brain or spinal cord injury or spinal tap, major regional anesthesia, or spinal anesthesia within the last 6 months\n    7. Esophageal varices\n    8. Arteriovenous malformation\n    9. Vascular aneurysms\n    10. Malignant tumor with a high risk of bleeding\n13. Bleeding tendencies associated with overt bleeding of\n\n    1. gastrointestinal, genitourinary, respiratory tract, or colorectal cancer\n    2. cerebrovascular hemorrhage\n    3. aneurysms- cerebral, dissecting aorta\n    4. pericarditis and pericardial effusions\n    5. bacterial endocarditis\n14. Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy\n15. Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted\n\n    * Switching anticoagulants\n    * Intravenous UFH to keep central\u002Farterial lines open\n16. Uncontrolled moderate or severe hypertension\n17. Anemia at least one among the conditions(as defined below) is met 1) Hemoglobin level \\\u003C10.0 g\u002FdL or platelet count \\\u003C 100 x 10x9\u002FL within the last 6 months 2) Diagnosed and documented ongoing anemia\n18. Infective endocarditis\n19. Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist\n20. Positive pregnancy test results (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days before screening and\u002For randomization) or during pregnancy or lactation\n21. A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n22. The unsuitable condition of the protocol\n23. Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period\n24. Terminal illness with life expectancy \\\u003C12 months\n25. Vitamin K deficiency\n26. Alcoholic or psychical disorder\n27. Threatened abortion, eclampsia, or preeclampsia\n28. Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of the acute coronary syndrome","ALL","19 Years",{"count":238,"type":239},1300,"ESTIMATED","INTERVENTIONAL",[242],"PHASE4","This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.",[245,246],"AORTIC VALVE DISEASES","Thromboembolism",[248,249],"Aortic valve replacement","Mechanical valve","2026-06-23",{"date":252,"type":253},"2026-06-24","ACTUAL",{"date":255,"type":253},"2022-02-21",{"date":257,"type":239},"2028-12-30",{"name":225,"class":6},16]