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NOT YET RECRUITING
NCT07677410
NA

Aspirin Monotherapy Versus Sequential Warfarin-Aspirin Therapy After TAVR in Patients With Pure Aortic Regurgitation

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Aspirin

Aspirin 75-100 mg orally once daily

DRUG

Warfarin

Warfarin orally with dose adjusted to maintain INR 2-3

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China