Status:
RECRUITING
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
Lead Sponsor:
St. Antonius Hospital
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Pitié-Salpêtrière Hospital
Conditions:
Severe Aortic Valve Stenosis
Eligibility:
All Genders
18-110 years
Phase:
NA
Brief Summary
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only ...
Eligibility Criteria
Inclusion
- Successful TAVI (according to the VARC-3 criteria)10 with any approved device
- Ability to understand and to comply with the study protocol
- Written informed consent
Exclusion
- Existing indication for oral anticoagulation (e.g. atrial fibrillation, obstructive valve thrombosis detected by echocardiography prior to inclusion)
- Existing indication for dual antiplatelet therapy at three months after TAVI (rare at this time point)
- Creatinine clearance \<15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT06168370
Start Date
December 1 2023
End Date
June 1 2028
Last Update
April 25 2024
Active Locations (1)
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1
St. Antonius Hospital
Nieuwegein, Netherlands