Comparing anticoagulation and aspirin after heart valve replacement
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
This study is testing whether a new blood thinner can help younger patients who have had heart valve replacement feel better and avoid complications compared to taking aspirin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 3 sites (Bergen and 2 other locations) |
| Trial ID | NCT05035277 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of anticoagulation therapy versus standard antiplatelet therapy following transcatheter aortic valve implantation in patients with aortic stenosis. It aims to determine if direct oral anticoagulants can prevent valve degeneration and improve safety outcomes compared to acetylsalicylic acid. The study will involve a pragmatic randomized controlled design with long-term follow-up to assess hard clinical outcomes. The trial is particularly relevant for the growing population of younger patients undergoing this procedure.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 to 80 who have successfully undergone transcatheter aortic valve implantation.
Not a fit: Patients with strict indications or contraindications for anticoagulation or antiplatelet drugs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes and reduced complications for patients undergoing transcatheter aortic valve implantation.
How similar studies have performed: Previous studies have suggested potential benefits of anticoagulation in similar contexts, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bergen and 2 other locations
- Haukeland University Hospital — Bergen, Norway (Not_yet_recruiting)
- Oslo Univesity Hospital - Ullevål — Oslo, Norway (Not_yet_recruiting)
- Oslo University Hospital - Rikshospitalet — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Øyvind H Lie, MD, PhD — Oslo University Hospital
- Study coordinator: Øyvind H Lie, MD, PhD
- Email: oyvlie@gmail.com
- Phone: +4793429011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.