Clinical Trial

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

Study acronym: POP ATLANTIS
Recruiting
View on ClinicalTrials.gov →
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 patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events. After 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-12-04; most recent amendment 2026-05-18.
Status change: Not Yet Recruiting → Recruiting 2024-04-24
Trial Details
NCT Number NCT06168370
Lead Sponsor St. Antonius Hospital
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Pitié-Salpêtrière Hospital
Conditions Severe Aortic Valve Stenosis
Enrollment 2,500 participants
Start Date 2023-12-01
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-19