Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprosthetic Heart Valve Replacement
Recruiting
Phase 4
Interventional Study
Valve Replacement Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 19 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,058 (estimated)
- Sponsor
- Asan Medical Center · Other
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About This Trial
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).
Trial Locations
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Eligibility Criteria
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 in…
Contacts