RecruitingPhase 4NCT05660811

Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed 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

Sponsor

National Institute of Cardiology, Warsaw, Poland

Enrollment

80 participants

Start Date

Sep 28, 2022

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

SAFE-LAAC CKD Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device in patients with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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

Interventions

DRUGshort postimplantation dual antiplatelet therapy

continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer Amulet

DRUGextended postimplantation dual antiplatelet therapy

stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer Amulet and continuing single antiplatelet agent up until 6 months

DRUGlong-term treatment with a single antiplatelet agent

continuing long-term treatment with single antiplatelet agent

DRUG6 months treatment with a single antiplatelet agent

continuing single antiplatelet agent up until 6 months