Comparing anticoagulation and antiplatelet therapy after heart device placement
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial
This study is testing whether a new blood-thinning medication works better than standard blood-thinning pills to prevent blood clots in patients who have had a heart device placed.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Quebec) |
| Trial ID | NCT03568890 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of short-term anticoagulation therapy using direct oral anticoagulants (DOACs) against antiplatelet therapy in preventing device thrombosis following transcatheter left atrial appendage closure (LAAC). The study will involve approximately 350 patients who have successfully undergone LAAC, assessing the incidence of device thrombosis over an 8-week period. Given the concern over device thrombosis rates that have not improved despite advancements in LAAC techniques, this trial seeks to determine if a shift to anticoagulation therapy could yield better outcomes. Participants will be monitored for thromboembolic events and bleeding complications during the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have successfully undergone transcatheter LAAC with an approved device.
Not a fit: Patients with contraindications to anticoagulation or antiplatelet therapy, or those with severe renal impairment or recent major bleeding events, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of device thrombosis in patients undergoing LAAC, improving patient safety and outcomes.
How similar studies have performed: While the approach of using anticoagulation therapy post-LAAC is being explored, the specific comparison of DOACs versus antiplatelet therapy in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Successful transcatheter LAAC with any approved device * Age≥18 years old Exclusion Criteria: * Absolute contraindications for anticoagulation therapy * Absolute contraindications for antiplatelet therapy * End-stage renal disease (CrCl \<15 ml/min) * Recent percutaneous revascularization with drug-eluting stents requiring dual antiplatelet therapy * Prior intracranial hemorrhage * Contraindications for TEE * Severe pericardial effusion within the first 24 hrs following LAAC * Major/life-threatening bleeding event within the month prior to LAAC * Multiple bleeding events (minor or major) within the month prior to LAAC * Major/life-threatening bleeding within the first 24 hrs following LAAC
Where this trial is running
Quebec
- Josep Rodes-Cabau — Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Josep Rodes-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 418-656-8711
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.