AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
Oslo University Hospital
360 participants
Dec 4, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Successful trans-catheter aortic valve implantation in patients aged >65 and <80 years old at the time of the procedure.
Exclusion Criteria5
- 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
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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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05035277