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Short versus long antiplatelet therapy after TAVI
EU CTIS ID: 2023-508208-40-00
What this study is testing
Non-inferiority of the experimental arm (90 days therapy with 75 to 100 mg oral aspirin) compared to standard arm (12 months therapy with 75 to 100 mg oral aspirin) on a composite clinical event at 12 months follow-up
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age ≥ 18
- • Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 o Successful access, delivery of the device, and retrieval of the delivery system o Correct positioning of a single prosthetic heart valve into the proper anatomical location o 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
- • 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
You likely can't join if
- • Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI
- • 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-
- • 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
See the full eligibility criteria
- • Age ≥ 18
- • Successful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 o Successful access, delivery of the device, and retrieval of the delivery system o Correct positioning of a single prosthetic heart valve into the proper anatomical location o 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
- • 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
- • Un-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI
- • 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-
- • 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…)
- • Adult with protective measures (tutorship, curatorship)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.