At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
In Brief
A Phase 3 clinical trial evaluating Acetylsalicylic acid, Apixaban, and 2 other interventions for Aortic Stenosis. Completed, enrolled 360 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Arms & Interventions
Patients in the active control arm will receive 75 mg acetylsalicylic acid once daily indefinitely.
Patients in the experimental arm will receive an anti Xa-type DOAC (apixaban, rivaroxaban or edoxaban) in approved therapeutic dose for 12 months. The choice of DOAC agent will be made by the treating clinician after discussion with the patient. After 12 months, these patients will abort DOAC therapy. Acetylsalicylic acid, 75 mg once daily will be started after DOAC discontinuation and continued indefinitely.
Interventions
Acetylsalicylic acid 75 mg once daily is the current standard-of-care in TAVI patients without other indications for anticoagulation therapy.
Standard dose apixaban will be one of the options for the patients in the experimental arm.
Standard dose rivaroxaban will be one of the options for the patients in the experimental arm.
Standard dose edoxaban will be one of the options for the patients in the experimental arm.