RecruitingPhase 4NCT07431762
Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement
Sponsor
Asan Medical Center
Enrollment
1,058 participants
Start Date
Jun 5, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 19 Years
Inclusion Criteria3
- 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.
Exclusion Criteria7
- 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)
- Unstable postoperative conditions at index point (i.e. requirement mechanical hemodynamic support, disabling complications, stroke \[ischemic, embolic\], hemorrhagic stroke)
- Hypersensitivity to the main component or constituents of aspirin or vitamin K antagonist
- Pregnant or lactating women
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Interventions
DRUGAspirin
100mg 1 tablet once daily for 6 months
DRUGVitamin K antagonist(warfarin)
Maintain an INR(International Normalized Ratio) of 2.0 to 3.0 for 6 months
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07431762