Overview

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Status:
Not yet recruiting

Trial end date:
2026-08-01

Target enrollment:
0

Participant gender:
All

Summary

ACASA-TAVI is a pragmatic randomized controlled trial assessing the value of anticoagulation therapy versus the standard antiplatelet therapy after transcatheter aortic valve implantation in patients with aortic stenosis. The trial will assess the efficacy of direct oral anticoagulation (DOAC) therapy compared to the standard single antiplatelet therapy to prevent degeneration of the valve and its safety in co-primary endpoints with blinded endpoint adjudication. The effect of DOAC therapy on hard clinical outcomes will be assessed during long-term follow-up.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oslo University Hospital

Collaborator:

University of Oslo

Treatments:

Apixaban
Aspirin
Edoxaban
Rivaroxaban

Criteria

Inclusion Criteria:

- Successful trans-catheter aortic valve implantation in patients aged >65 and <80 years
old at the time of the procedure.

Exclusion Criteria:

- Strict indication for anticoagulation or anti-platelet drugs

- Strict contraindication for anticoagulation or anti-platelet drugs

- Overt cognitive failure

- Failure to obtain written informed consent

- Concomitant use of inducers or inhibitors of CYP3A4 or P-glycoprotein