Actively Recruiting

Phase 3
Age: 65Years - 80Years
All Genders
NCT05035277

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Led by Oslo University Hospital · Updated on 2022-11-14

360

Participants Needed

3

Research Sites

256 weeks

Total Duration

On this page

Sponsors

O

Oslo University Hospital

Lead Sponsor

U

University of Oslo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation

Who Can Participate

Age: 65Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Successful transcatheter aortic valve implantation
  • Age greater than 65 years and less than 80 years at the time of the procedure
Not Eligible

You will not qualify if you...

  • Strict indication for anticoagulation or antiplatelet drugs
  • Strict contraindication for anticoagulation or antiplatelet drugs
  • Overt cognitive failure
  • Failure to obtain written informed consent
  • Concomitant use of inducers or inhibitors of CYP3A4 or P-glycoprotein

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Haukeland University Hospital

Bergen, Norway, 5021

Not Yet Recruiting

2

Oslo Univesity Hospital - Ullevål

Oslo, Norway, 0424

Not Yet Recruiting

3

Oslo University Hospital - Rikshospitalet

Oslo, Norway, 0772

Actively Recruiting

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Research Team

Ø

Øyvind H Lie, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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