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Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement

RecruitingPhase 4Ages 19 Years - anyAllAsan Medical Center
NCT07431762 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged ≥ 19 years with successful surgical bioprosthetic valve replacement 2. Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively 3. 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/Ethical Committee of the respective clinical site. Exclusion Criteria: 1. Mechanical valve in any heart valve position 2. Previous hemorrhagic stroke within the last 3 months 3. Clinically overt stroke within the last 3 months 4. Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis) 5. Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamic support, disabling complications, stroke \[ischemic, embolic\], hemorrhagic stroke) 6. Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist 7. Pregnant or lactating women
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What it tests

  • Aspirin
  • Vitamin K antagonist(warfarin)
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Where

3 sites
National Cerebral and Cardiovascular Center Hospital
Osaka, Japan
Osaka University Hospital
Osaka, Japan
Asan Medical Center
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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