NCT06168370Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 20 Oct 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- St. Antonius Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06168370
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From 1 Dec 2023 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Lab values
- Creatinine clearance \<15 mL/min (based on the CKD-EPI formula) or on renal replacement therapy
Who the study is looking for
- 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
Age in the registry: 18 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.