Short Versus Long Antiplatelet Therapy After TAVI

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Caen University Hospital
RECRUITING
Caen
Contact Information
Primary
Farzin Beygui, MD,PhD
beygui-f@chu-caen.fr
+33231063350
Backup
Clemence Thomadesso, PhD
tomadesso-c@chu-caen.fr
+33231065386
Time Frame
Start Date: 2024-11-21
Estimated Completion Date: 2029-01
Participants
Target number of participants: 1400
Treatments
Experimental: Short treatment
Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation
Active_comparator: long treatment
Long term (lifetime) single antiplatelet therapy75 to 100 mg aspirin therapy after TAV
Sponsors
Leads: University Hospital, Caen

This content was sourced from clinicaltrials.gov

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