Personalized, CT-guided antithrombotic therapy versus lifelong single antiplatelet therapy to reduce thromboembolic and bleeding events in non-atrial fibrillation patients after transcatheter aortic valve implantation: a pragmatic, international, multicentre, randomized clinical trial (POPular ATLANTIS trial)
Phase 1
- Conditions
- aortic valve stenosisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-504637-42-01
- Lead Sponsor
- St Antonius Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1950
Inclusion Criteria
Successful TAVI (according to the VARC-3 criteria) with any approved device, Ability to understand and to comply with the study protocol, Written informed consent
Exclusion Criteria
Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion), Creatinine clearance <15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method