The Danish Warfarin-Dialysis Study: Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis - A Nationwide Parallel-group Open Randomized Clinical Trial

What this Trial Is About

This research aims to evaluate whether starting oral anticoagulation with Warfarin reduces stroke risk safely and effectively in patients with end-stage renal disease who are on dialysis and have atrial fibrillation. The study addresses the lack of clear evidence on the benefits and risks of anticoagulation in this population, as they are often excluded from trials. It is a nationwide, open-label, randomized trial designed to provide conclusive data on the use of Warfarin for stroke prevention in these patients. Participants will be randomly assigned to one of two groups: one receiving Warfarin with dosing adjusted to maintain an international normalized ratio (INR) of 2 to 3, and the other receiving no treatment. The trial plans to enroll 718 dialysis patients with atrial fibrillation, following them for at least one year with ongoing monitoring. The randomization is stratified by gender, age, and center, and the study will last up to four years to observe outcomes. During the study, participants will be regularly monitored for safety and effectiveness outcomes, including ischemic or unspecified strokes, transient ischemic attacks, major bleeding events, and death. The primary outcomes focus on the number of participants experiencing stroke or major bleeding from the time of randomization up to four years. Secondary outcomes include various stroke subtypes and mortality rates. The study includes ongoing assessments to track safety and tolerability throughout the observation period.

The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis