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

Recruiting now · Phase 4

Conditions studied: Valve Replacement Surgery

In brief

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).

Key facts

Study ID

NCT07431762

Run by

Asan Medical Center

People needed

1058

Starts

2026-06-05

Expected to finish

2031-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Asan Medical Center — Seoul, South Korea (enrolling)
• National Cerebral and Cardiovascular Center Hospital — Osaka, Japan
• Osaka University Hospital — Osaka, Japan

Full record on ClinicalTrials.gov

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