Aspirin vs Warfarin after Bioprosthetic Heart Valve Replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multinational, multicenter randomized trial comparing two antithrombotic strategies after tissue valve replacement: aspirin versus a vitamin K antagonist (warfarin) during the initial six months. It is open-label and actively controlled, focusing on safety outcomes. Eligible participants are adults who recently had a bioprosthetic aortic or mitral valve replacement and do not require ongoing anticoagulation for other conditions. Exclusion criteria include mechanical valves, recent strokes, need for anticoagulation, unstable postoperative status, aspirin or warfarin hypersensitivity, and pregnancy. The study is led by Asan Medical Center with participating centers in Osaka and Seoul.

Why it matters

Who can join: the full rules

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

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting
• National Cerebral and Cardiovascular Center Hospital
  Osaka, Japan Not yet recruiting
• Osaka University Hospital
  Osaka, Japan Not yet recruiting

Study contacts

• Study coordinator: Joon-bum Kim, MD
• Email: jbkim1975@amc.seoul.kr
• Phone: 82230105416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.