Short Versus Long Antiplatelet Therapy After TAVI
University Hospital, Caen
1,400 participants
Nov 21, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria9
- Age ≥ 18
- Male or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female
- Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33
- Successful access, delivery of the device, and retrieval of the delivery system
- Correct positioning of a single prosthetic heart valve into the proper anatomical location
- Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication
- Written informed consent
- Social security affiliated
- French speaking
Exclusion Criteria17
- Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI3
- Alternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches
- TAVI for other indications than aortic stenosis (pure aortic regurgitation)
- Valve in valve TAVI
- Any indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization
- Any indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization
- Patients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI
- Any contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia \< 50 000, major haemostasis disorder…)
- Women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-
- Adult with protective measures (tutorship, curatorship)
- Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:
- Patients with known or discovered severe cognitive impairment
- Patients with treated or untreated severe psychological or psychiatric conditions
- Patients with uncorrected severe hearing or visual handicap
- Patients with addictive alcohol, drug or substance abuse
- Patients with protective measures (guardianship, tutorship, curatorship)
- Any other condition considered by the investigators as not warranting informed consent
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Interventions
Short duration of aspirin (3 months) is compared to long duration of aspirin (12 months)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06518317