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

NARecruitingINTERVENTIONAL
Enrollment

2,500

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

January 1, 2028

Study Completion Date

June 1, 2028

Conditions
Severe Aortic Valve Stenosis
Interventions
RADIATION

CT 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."

Trial Locations (1)

Unknown

RECRUITING

St. Antonius Hospital, Nieuwegein

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Pitié-Salpêtrière Hospital

OTHER

lead

St. Antonius Hospital

OTHER