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Short Versus Long Antiplatelet Therapy After TAVI

Study acronym: SOLOTAVI
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jul 2028 to Nov 2028
    • Study completion date: Sep 2028 to Jan 2029
    • Start date changed from estimate of Sep 2024 to Nov 21, 2024
  2. Start date: Jul 2024 to Sep 2024v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06518317
Lead Sponsor University Hospital, Caen
Conditions
(from sponsor)		 Transcatheter Aortic Valve Replacement
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov