Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.
VARC-3 WRITING COMMITTEE, Philippe Généreux, Nicolo Piazza...
https://pubmed.ncbi.nlm.nih.gov/33871579Actively Recruiting
Phase 3
Age: 65Years - 80Years
All Genders
ID05035277
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation in Patients with Aortic Stenosis
Led by Oslo University Hospital · Updated on 2022-11-14
360
Participants Needed
3
Research Sites
N/A
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
This research is focused on patients with aortic stenosis who have undergone transcatheter aortic valve implantation (TAVI). It evaluates the value of anticoagulation therapy compared to the current standard single antiplatelet therapy in preventing valve degeneration and improving safety outcomes. The study is a pragmatic randomized controlled trial designed to assess these treatments in an elderly population aged 65 to 80 years. Participants are randomly assigned to one of two groups: one group receives a direct oral anticoagulant (DOAC) of the anti-Xa type, such as apixaban, rivaroxaban, or edoxaban, for 12 months without antiplatelet therapy, followed by acetylsalicylic acid (ASA) once daily indefinitely. The other group receives ASA 75 mg once daily indefinitely from the start. The treatments will be compared for their effects on valve maintenance and safety, with clinical assessments including cardiac CT and echocardiography at 12 months. During the study, participants will undergo evaluations to monitor valve function and safety outcomes over 12 months, including blinded endpoint adjudication. The primary outcomes include valve leaflet thickening and a safety composite at 12 months, with long-term follow-up for major adverse cardiovascular events at 5 and 10 years. The trial includes detailed assessments of bleeding, thromboembolic events, mortality, and adverse events, ensuring thorough monitoring throughout the study period.
CONDITIONS
Brief Title
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
Who Can Participate
Age: 65Years - 80Years
All Genders
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 12 months
Participants receive either a direct oral anticoagulant (DOAC) for 12 months or acetylsalicylic acid daily as standard treatment following transcatheter aortic valve implantation.
Regular visits during the 12 months of treatment for clinical assessment and monitoring
Follow-up
Duration - Up to 9 years
After 12 months, participants who received DOAC switch to acetylsalicylic acid maintenance therapy. Long-term follow-up continues to monitor major adverse cardiovascular events up to 10 years.
Periodic visits for long-term monitoring of cardiovascular events
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
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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Published Research Related To This Trial
An investigator-sponsored pragmatic randomized controlled trial of AntiCoagulation vs AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation: Rationale and design of ACASA-TAVI.
Christopher S Dodgson, Jan Otto Beitnes, Sophie F Kløve...
https://pubmed.ncbi.nlm.nih.gov/37634655