NCT06168370 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
| NCT ID | NCT06168370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Antonius Hospital |
| Condition | Severe Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,500 participants in total. It began in 2023-12-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06168370 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Severe Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06168370 currently recruiting?
Yes, NCT06168370 is actively recruiting participants. Contact the research team at c.overduin@antoniusziekenhuis.nl for enrollment information.
Where is the NCT06168370 trial being conducted?
This trial is being conducted at Nieuwegein, Netherlands.
Who is sponsoring the NCT06168370 clinical trial?
NCT06168370 is sponsored by St. Antonius Hospital. The trial plans to enroll 2,500 participants.