Last reviewed · How we verify
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation (ACASA-TAVI)
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.
Details
| Lead sponsor | Oslo University Hospital |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 360 |
| Start date | 2021-12-04 |
| Completion | 2026-11 |
Conditions
- Aortic Stenosis
Interventions
- Acetylsalicylic acid
- Apixaban
- Rivaroxaban
- Edoxaban
Primary outcomes
- Hypo-attenuated leaflet thickening — 12 months
First co-primary endpoint. The presence of hypo-attenuated leaflet thickening on dedicated cardiac CT after 12 months will be registered by a blinded expert reader. Intention-to-treat, superiority. - Safety composite - Incidence of Treatment Emergent Adverse Clinical Outcome — 12 months
Second co-primary outcome. Composite of VARC-3 bleeding events, thromboembolic events (myocardial infarction or stroke) and all-cause mortality. Per-protocol, non-inferiority. - Major adverse cardiovascular events (MACE) — 5 years
Primary outcome during long-term follow-up. The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding. - Major adverse cardiovascular events (MACE) — 10 years
Primary outcome during long-term follow-up. The rate of the composite of Cardiac death, Aortic valve re-intervention, Stroke, Myocardial infarction, Heart failure hospitalization and Major, life-threatening, or disabling bleeding.
Countries
Norway