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AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

NCT05035277 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2022-11-14

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis

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.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Øyvind H Lie, MD, PhD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-04
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05035277 on ClinicalTrials.gov