Optimal antiplatelet therapy after left atrial appendage closure in dialysis patients
Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure - Chronic Kidney Disease (SAFE LAAC CKD). Comparative Health Effectiveness Ancillary Study - PILOT
PHASE4 · National Institute of Cardiology, Warsaw, Poland · NCT05660811
This study is testing which length of dual antiplatelet therapy is safer and more effective for dialysis patients after they have a procedure to close off the left atrial appendage.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institute of Cardiology, Warsaw, Poland (other) |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT05660811 on ClinicalTrials.gov |
What this trial studies
The SAFE-LAAC CKD Trial aims to determine the best antiplatelet therapy regimen following successful left atrial appendage closure (LAAC) in patients with end-stage renal disease on dialysis. This interventional study 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 80 patients who have undergone LAAC with either the Amplatzer or WATCHMAN device. The findings will help address the lack of data on optimal antithrombotic strategies in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with end-stage renal disease on chronic dialysis who have successfully undergone LAAC.
Not a fit: Patients with indications for dual antiplatelet therapy unrelated to LAAC or those requiring anticoagulation for other conditions 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 in dialysis patients after LAAC, potentially reducing the risk of stroke and bleeding.
How similar studies have performed: While studies on LAAC have been conducted, this specific approach focusing on dialysis patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days prior to randomization * End-stage renal disease treated with chronic haemodialysis or peritoneal dialysis * 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 left atrial appendage occlusion at the time of enrollment and/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). Does not apply to anticoagulation used during dialysis * Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol * 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/or preceding 3 months * 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 a negative pregnancy test 24 hours before 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.
Conditions: Atrial Fibrillation, atrial fibrillation, stroke, bleeding, left atrial appendage, dialysis