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AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

RECRUITINGPhase 3Sponsored by Oslo University Hospital
Actively Recruiting
PhasePhase 3
SponsorOslo University Hospital
Started2021-12-04
Est. completion2026-11
Eligibility
Age65 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05035277

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

Age: 65 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* Successful trans-catheter aortic valve implantation in patients aged \>65 and \<80 years old at the time of the procedure.

Exclusion Criteria:

* 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

Conditions2

Aortic StenosisHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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