Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
Recruiting
N/A
Interventional Study
Aortic Regurgitation Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,172 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Other
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About This Trial
This multicenter randomized controlled trial evaluates antithrombotic strategies post-TAVR in severe aortic regurgitation patients without long-term anticoagulation. Patients are randomized 1:1 to aspirin 75-100 mg daily for 12 months versus warfarin (INR 2-3) for 6 months followed by aspirin for 6 months. Primary hypothesis: aspirin is superior for bleeding and non-inferior for death/thrombosis. …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years.
* Patients with severe aortic regurgitation (AR) who achieve technical success after TAVR using devices specifically indicated for AR (per VARC-3 criteria).
* Trileaflet aortic valve anatomy.
* No long-term anticoagulation indication (including but not limited t…
Contacts