Comparing short and long aspirin therapy after heart valve replacement

Short Versus Long Antiplatelet Therapy After TAVI

This study is testing if taking aspirin for just 3 months after heart valve replacement is as safe and effective as the usual 12 months for adults who have had the procedure.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Caen (Academic / other)
• Locations: 1 site (Caen)
• Trial ID: NCT06518317 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine whether a shorter duration of aspirin treatment (3 months) after transcatheter aortic valve replacement (TAVI) is as safe and effective as the standard longer duration (12 months). The study will involve adult patients who have successfully undergone TAVI for symptomatic aortic stenosis and have no other indications for long-term antiplatelet therapy. Participants will be monitored for bleeding and cardiovascular events through regular follow-ups and diary entries during the study period. The goal is to assess if reducing aspirin treatment can lower bleeding risks without increasing cardiovascular complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have successfully undergone transfemoral TAVI for symptomatic aortic stenosis without indications for long-term antiplatelet or anticoagulant therapy.

Not a fit: Patients who have had unsuccessful TAVI or those requiring alternative non-femoral approaches will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer treatment protocols for patients undergoing TAVI, reducing the risk of bleeding complications.

How similar studies have performed: Other studies have explored antiplatelet therapy durations, but this specific comparison of short versus long aspirin therapy post-TAVI is novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Caen

• Caen University Hospital — Caen, France (Recruiting)

Study contacts

• Study coordinator: Farzin Beygui, MD,PhD

Conditions Transcatheter Aortic Valve Replacement