Optimal antiplatelet therapy after left atrial appendage closure
Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study
This study is testing which length of antiplatelet therapy is better for people who have had a left atrial appendage closure procedure to see if stopping all blood thinners after six months or continuing with one can keep them safe and healthy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT03445949 on ClinicalTrials.gov |
What this trial studies
The SAFE-LAAC Trial aims to determine the best antiplatelet therapy strategy following transcatheter left atrial appendage closure using the Amplatzer or WATCHMAN device. This multicenter, open-label trial will compare the safety and efficacy of two durations of dual antiplatelet therapy (30 days vs. 6 months) and evaluate the outcomes of stopping all antithrombotic agents after 6 months versus continuing with a single antiplatelet agent. The study will involve 200 patients who have successfully undergone left atrial appendage closure. The results will inform clinical guidelines and future research on optimal antithrombotic treatment post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have successfully undergone left atrial appendage closure with either the Amplatzer or WATCHMAN device.
Not a fit: Patients with indications for dual antiplatelet therapy unrelated to atrial fibrillation or those requiring anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and efficacy of antiplatelet therapy for patients undergoing left atrial appendage closure.
How similar studies have performed: Other studies have explored antiplatelet therapy in similar contexts, but this specific comparative approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization * Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization * Participant's age 18 years or older at the time of signing the informed consent form * Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen * Participant is willing to sign the study informed consent form Exclusion Criteria: * Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization) * Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism) * Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol * Any known inborn or acquired coagulation disorders * Peridevice leak \>5mm on imaging study preceding enrollment * Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment * Life expectancy of fewer than 18 months * Participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months * Chronic kidney disease stage IV and V * Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with negative pregnancy test 24 hours prior to randomization if \<55 years old) or after surgical sterilization
Where this trial is running
Warsaw, Masovian Voivodeship
- National Institute of Cardiology — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Radoslaw Pracon, MD PhD — Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
- Study coordinator: Radoslaw Pracon, MD PhD
- Email: rpracon@ikard.pl
- Phone: 22 343 43 42
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.