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RECRUITING
NCT05035277
PHASE3

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2021-12-04

Completion Date

2026-11

Last Updated

2022-11-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

Acetylsalicylic acid

Acetylsalicylic acid 75 mg once daily is the current standard-of-care in TAVI patients without other indications for anticoagulation therapy.

DRUG

Apixaban

Standard dose apixaban will be one of the options for the patients in the experimental arm.

DRUG

Rivaroxaban

Standard dose rivaroxaban will be one of the options for the patients in the experimental arm.

DRUG

Edoxaban

Standard dose edoxaban will be one of the options for the patients in the experimental arm.

Locations (3)

Haukeland University Hospital

Bergen, Norway

Oslo Univesity Hospital - Ullevål

Oslo, Norway

Oslo University Hospital - Rikshospitalet

Oslo, Norway