Actively Recruiting
Comparing Short 3 months Versus Long Lifetime Aspirin Treatment After Transcatheter Aortic Valve Replacement TAVI
Led by University Hospital, Caen · Updated on 2025-03-26
1400
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether reducing the duration of aspirin treatment to 3 months after percutaneous aortic valve replacement is as safe and effective as the routine lifetime aspirin therapy. The study focuses on patients with symptomatic aortic stenosis who have undergone successful transfemoral transcatheter aortic valve implantation TAVI and have no other indication for long-term antiplatelet or anticoagulant therapy. The main goal is to determine if a shorter aspirin treatment lowers bleeding rates without increasing cardiovascular risks. Participants are randomly assigned to one of two groups one receiving aspirin at doses of 75 to 100 mg daily for 3 months followed by stopping aspirin, and the other receiving long-term aspirin therapy at the same dose after TAVI. The study follows patients for 12 months, with assessments at 3, 4, 6, 8, 10, and 12 months after hospital discharge. The design is an open-label, randomized trial with blinded evaluation of outcomes. During the study, participants will keep a diary to record any bleeding or cardiovascular events. Researchers will monitor the net clinical benefit, including death, heart attack, stroke, and major bleeding, over 12 months. Participants will have regular phone contacts or clinic visits for evaluation. The trial aims to include 1400 patients, and safety and effectiveness will be assessed through these detailed follow-ups.
CONDITIONS
Brief Title
Short Versus Long Antiplatelet Therapy After TAVI
Research Team
F
Farzin Beygui, MD,PhD
C
Clemence Thomadesso, PhD
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