Short Versus Long Antiplatelet Therapy After TAVI

NCT06518317 | Recruiting Phase 3 DMC

• 1 other identifier: 2023-508208-40-00
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Net clinical benefit

  The composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system injury and non-procedure-related major or disabling bleeding VARC 3 types 2 or 3

  12 months after randomisation

Secondary Outcomes (3)

• Non-procedure-related bleeding

  12 months

• Major or disabling or life threatening bleeding

  12 months

• Major cardiovascular events

  12 months

Other Outcomes (14)

• Minor bleeding

  12 months

• Major bleeding

  12 months

• Disabling or life threatening bleeding

  12 months

Study Arms (2)

Short treatment

EXPERIMENTAL

Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation

Drug: Aspirin

long treatment

ACTIVE COMPARATOR

Long term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAV

Drug: Aspirin

Interventions

Aspirin DRUG

Short duration of aspirin (3 months) is compared to long duration of aspirin (12 months)

Short treatment; long treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, 14990, France

RECRUITING

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Farzin Beygui, MD,PhD

CONTACT

+33231063350; beygui-f@chu-caen.fr

Clemence Thomadesso, PhD

CONTACT

+33231065386; tomadesso-c@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)