Short Versus Long Antiplatelet Therapy After TAVI
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aspirin
Treatment groups
1,400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov