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AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
Sponsor: Oslo University Hospital
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
Acetylsalicylic acid
Acetylsalicylic acid 75 mg once daily is the current standard-of-care in TAVI patients without other indications for anticoagulation therapy.
Apixaban
Standard dose apixaban will be one of the options for the patients in the experimental arm.
Rivaroxaban
Standard dose rivaroxaban will be one of the options for the patients in the experimental arm.
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