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
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
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
Parallel
short postimplantation dual antiplatelet therapy
Drugcontinuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer Amulet
extended postimplantation dual antiplatelet therapy
Drugstopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer Amulet and continuing single antiplatelet agent up until 6 months
long-term treatment with a single antiplatelet agent
Drugcontinuing long-term treatment with single antiplatelet agent
6 months treatment with a single antiplatelet agent
Drugcontinuing single antiplatelet agent up until 6 months
Efficacy (a composite of ischemic stroke, transient ischaemic attack, peripheral embolism, nonfatal myocardial infarction, cardiovascular mortality, all-cause mortality, left atrial appendage thrombus)
Event rates reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);
Safety (moderate and/or severe bleeding (BARC type 2, 3, and 5)
Event rates reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);
Ischemic stroke
Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);
Transient ischaemic attack
Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);
Peripheral embolism
Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);
Nonfatal myocardial infarction
Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);
Number of new ischemic brain lesions on magnetic resonance imaging
Volume of new ischemic brain lesions on magnetic resonance imaging
The change from baseline in the cumulative dose of heparin anticoagulation used during haemodialysis
The change from baseline in the dose of erythropoietin used
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National Institute of Cardiology, Warsaw, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator
