Clinical Research Directory
Browse clinical research sites, groups, and studies.
Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation
Sponsor: Shanghai Zhongshan Hospital
Summary
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. Primary endpoint is a composite of death, stroke, thrombosis, MI, embolism, and major bleeding at 1 year. Sample size: 1172. Follow-up: 30 days, 6 months, 12 months.
Official title: Prospective, Multicenter, Randomized Controlled Trial Evaluating the Safety and Efficacy of Different Antithrombotic Therapy Strategies in Patients With Severe Aortic Regurgitation Undergoing Transcatheter Aortic Valve Replacement
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1172
Start Date
2026-07-01
Completion Date
2030-07-01
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
Aspirin
Aspirin 75-100 mg orally once daily
Warfarin
Warfarin orally with dose adjusted to maintain INR 2-3
Locations (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China