Actively 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
Led by St. Antonius Hospital · Updated on 2024-04-25
2500
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
S
St. Antonius Hospital
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Successful TAVI according to VARC-3 criteria with any approved device
- Ability to understand and comply with the study protocol
- Written informed consent
You will not qualify if you...
- Existing indication for oral anticoagulation such as atrial fibrillation or valve thrombosis detected by echocardiography before inclusion
- Existing indication for dual antiplatelet therapy at three months after TAVI
- Creatinine clearance less than 15 mL/min or on renal replacement therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Antonius Hospital
Nieuwegein, Netherlands
Actively Recruiting
Research Team
C
Christiaan Overduin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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