Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Red… (NCT06168370) | Clinical Trial Compass
RecruitingNot Applicable
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
Netherlands2,500 participantsStarted 2023-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 110 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a personalized, CT-guided antithrombotic approach against lifelong single antiplatelet therapy after TAVI — can you explain what 'CT-guided' means in this context and how that imaging would actually change the blood-thinning medication I'd be prescribed?
2Since this trial is measuring both thromboembolic events like stroke or clot and all types of bleeding as its main outcomes, how does my personal risk for each of those compare, and does that affect whether this kind of study would be a good fit for my situation?
3This trial is listed as Phase NA, which can mean it's a practical or comparative effectiveness study rather than an early safety trial — can you help me understand what that means for how much is already known about the safety of the approaches being compared?
4If I were to take part in this trial, how would the CT imaging and personalized medication adjustments fit into my recovery schedule after a TAVI procedure, and would that require extra clinic visits or imaging appointments I need to plan around?
5Would starting with the standard single antiplatelet therapy that's already commonly used after TAVI be a reasonable first step for me, and under what circumstances might you recommend reconsidering or discussing this trial instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Thromboembolic events
Timeframe: Through study completion, a median of 2.5 years
2
All bleeding
Timeframe: Through study completion, a median of 2.5 years