Clinical Trial

Short Versus Long Antiplatelet Therapy After TAVI

Study acronym: SOLOTAVI
Recruiting Phase 3
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Summary
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin (standard treatment regimen). The main questions it aims to answer are: Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events. Researchers will compare a short treatment by aspirin (3 months) to a long treatment by aspirin (12 months) after percutaneous replacement of the aortic valve. Participants will: Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3, 4, 6, 8, 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-07-18; most recent amendment 2025-03-24.
Status change: Not Yet Recruiting → Recruiting 2025-03-24
Trial Details
NCT Number NCT06518317
Lead Sponsor University Hospital, Caen
Conditions Transcatheter Aortic Valve Replacement
Enrollment 1,400 participants
Start Date 2024-11-21
Primary Completion 2028-11 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-26