Study of Apixaban for Stroke Prevention in Adults with Stage 5 Chronic Kidney Disease and Atrial Fibrillation

What this Trial Is About

Researchers are evaluating the effectiveness and safety of apixaban as a stroke prevention treatment in adults with stage 5 chronic kidney disease CKD who also have atrial fibrillation AF or atrial flutter AFL. This study compares apixaban to no anticoagulation to see if it reduces the risk of ischemic stroke without increasing fatal or brain bleeding events. The trial also examines all-cause mortality, cardiovascular events, and major bleeding risks in this patient group. Participants are randomly assigned to one of two groups one receiving apixaban 2.5 mg twice daily plus standard care, and the other receiving standard care without anticoagulation. The study is open-label and conducted over 12 to 72 months across around 50 sites in several European countries. Patients already on warfarin, apixaban, or low molecular weight heparin may join after stopping their current anticoagulation. Routine blood tests are done at inclusion. During the trial, participants will be monitored for ischemic stroke, intracranial or fatal bleeding, death, cardiovascular events, and major bleeding according to established criteria. Additional outcomes include thromboembolic events and kidney transplant-related complications. The study lasts up to 72 months per participant or until a set number of events occur. Safety and efficacy data are reviewed by independent boards throughout the study.

Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation