Actively Recruiting
Short Versus Long Antiplatelet Therapy After TAVI
Led by University Hospital, Caen · Updated on 2025-03-26
1400
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Short Versus Long Antiplatelet Therapy After TAVI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Male or post-menopausal or permanently sterilized female
- Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 criteria
- Written informed consent
- Affiliated with social security
- French speaking
You will not qualify if you...
- Unsuccessful TAVI procedure
- Non-femoral TAVI approaches (apical, trans-aortic, subclavian, axillary, carotid)
- TAVI for conditions other than aortic stenosis (e.g. pure aortic regurgitation)
- Valve-in-valve TAVI
- Any indication for long-term antiplatelet therapy prior to randomization
- Any indication for oral anticoagulation prior to randomization
- Prior long-term antiplatelet or anticoagulant therapy before TAVI for reasons other than TAVI
- Contraindications to long-term antiplatelet therapy (e.g. aspirin allergy, major bleeding, high bleeding risk, low platelets, bleeding disorders)
- Women of childbearing potential who are not post-menopausal or not permanently sterilized
- Adults under protective measures such as tutorship or curatorship
- Patients considered vulnerable due to severe cognitive, psychological, sensory impairments or substance abuse
- Any other condition deemed by investigators to prevent informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Caen University Hospital
Caen, France, 14990
Actively Recruiting
Research Team
F
Farzin Beygui, MD,PhD
CONTACT
C
Clemence Thomadesso, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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