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).
Aged ≥ 19 years with successful surgical bioprosthetic valve replacement
Bioprosthetic heart valve in aortic or mitral valve positions, for a day postoperatively
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.
Mechanical valve in any heart valve position
Previous hemorrhagic stroke within the last 3 months
Clinically overt stroke within the last 3 months
Current need for anticoagulation (i.e. atrial fibrillation, deep vein thrombosis)
Parallel
Aspirin
Drug100mg 1 tablet once daily for 6 months
Vitamin K antagonist(warfarin)
DrugMaintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months
A composite endpoint is defined as a single outcome that combines multiple clinical events; the occurrence of any one of the component events is considered as meeting the endpoint.
Rate of all-cause mortality within 6 months
Number of participants who experienced stroke within 6 months
Number of participants who experienced transient ischemic attack within 6 months
Number of participants who experienced systemic embolism within 6 months
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