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Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients

NCT05660811 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-06-25

No results posted yet for this study

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

Conditions

Interventions

DRUG

short postimplantation dual antiplatelet therapy

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

DRUG

extended 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

DRUG

long-term treatment with a single antiplatelet agent

continuing long-term treatment with single antiplatelet agent

DRUG

6 months treatment with a single antiplatelet agent

continuing single antiplatelet agent up until 6 months

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Radoslaw Pracon, MD PhD · Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660811 on ClinicalTrials.gov