RecruitingNot ApplicableNCT06168370

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

Sponsor

St. Antonius Hospital

Enrollment

2,500 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Severe Aortic Valve Stenosis

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

Min Age: 18 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two blood-thinning strategies — personalized CT-guided therapy versus lifelong single antiplatelet therapy — to reduce clotting and bleeding risk after a transcatheter aortic valve implantation (TAVI) procedure in people without atrial fibrillation. You may be eligible if... - You have had a successful TAVI procedure using any approved device - You are able to understand and follow the study protocol - You have provided written informed consent You may NOT be eligible if... - You already need blood thinners for another reason (e.g., atrial fibrillation, or a blood clot found on your new valve) - You need dual antiplatelet therapy at 3 months after TAVI - Your kidney function is very poor (creatinine clearance below 15 mL/min) or you are on dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONCT guided strategy

1. With signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI are switched from SAPT to apixaban. Patients fulfilling the dose reduction criteria according to the drug label, or with a Clinical Frailty Scale ≥4 will receive 2.5mg bid, patients not meeting these criteria will receive a standard dose of 5mg bid. 2. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI, without another indication for antiplatelet therapy stop their SAPT. 3. Without signs of subclinical valve thrombosis on 4D-CT at 3 months after TAVI with another indication for antiplatelet therapy continue life-long SAPT.