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Clinical Trial Details

Trial ID: L1735
Source ID: NCT05660811
Associated Drug: Short Postimplantation Dual Antiplatelet Therapy
Title: Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients
Acronym: SAFE LAAC CKD
Status: RECRUITING
Study Results: NO
Results:
Conditions: Atrial Fibrillation
Interventions: DRUG: short postimplantation dual antiplatelet therapy|DRUG: extended postimplantation dual antiplatelet therapy|DRUG: long-term treatment with a single antiplatelet agent|DRUG: 6 months treatment with a single antiplatelet agent
Outcome Measures: Primary: 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);, 17 months|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);, 17 months | Secondary: Ischemic stroke, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Transient ischaemic attack, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Peripheral embolism, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Nonfatal myocardial infarction, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Cardiovascular mortality, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|All-cause mortality, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Moderate and/or severe bleeding (BARC type 2,3, and 5), Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Left atrial appendage thrombus, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Any bleeding, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|New moderate or major (≥4 mm) ischemic brain lesions on magnetic resonance imaging, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Change in cognition score as detected by the Addenbrooke's cognitive examination (ACE-III), ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual, and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning., 17 months|Dialysis access thrombosis, Event rate reported per 100 patient-years (calculated as 100\*Number of Participants with events/Total patient-years);, 17 months|Safety and efficacy of the procedure in the periprocedural period and 1-month follow-up based on registry data, 1-month event rate of: cardiac arrest, device embolism, tamponade, pericardial effusion, stroke/TIA/myocardial infarction/peripheral embolus, access site bleeding/vascular complications, bleeding complications unrelated to access site (Number of Participants with event/Total patient number), 1-month | Other: Number of new ischemic brain lesions on magnetic resonance imaging, 17 months|Volume of new ischemic brain lesions on magnetic resonance imaging, 17 months|The change from baseline in the cumulative dose of heparin anticoagulation used during haemodialysis, 17 months|The change from baseline in the dose of erythropoietin used, 17 months
Sponsor/Collaborators: Sponsor: National Institute of Cardiology, Warsaw, Poland | Collaborators: Medical Research Agency, Poland
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-09-28
Completion Date: 2026-06
Results First Posted:
Last Update Posted: 2024-06-25
Locations: National Institute of Cardiology, Warsaw, Mazowieckie, 04-628, Poland
URL: https://clinicaltrials.gov/show/NCT05660811