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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Poland
National Institute of Cardiology
RECRUITING
Warsaw
Contact Information
Primary
Radoslaw Pracon, MD PhD
rpracon@ikard.pl
22 343 43 42
Backup
Marcin Demkow, MD PhD
mdemkow@ikard.pl
22 343 43 42
Time Frame
Start Date:2022-09-28
Estimated Completion Date:2026-06
Participants
Target number of participants:80
Treatments
Other: 30 days DAPT and long-term treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
Other: 6 months DAPT and long-term treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
Other: 30 days DAPT and 6 months treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
Other: 6 months DAPT and 6 months treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent