Comparing Warfarin, Edoxaban, and No Anticoagulation for Atrial Fibrillation in Patients with Severe Kidney Disease

What this Trial Is About

The VISIONAIRE trial studies patients with atrial fibrillation or atrial flutter who also have advanced chronic kidney disease. This phase 4, randomized clinical trial is designed to compare three blood-thinning strategies to manage the risk of blood clots in this population, aiming to understand their effects on safety and effectiveness. The trial is sponsored by Hospital Sirio-Libanes and includes 1500 participants. Participants will be randomly assigned to one of three groups full-dose warfarin adjusted to a target INR between 2.0 and 3.0, a fixed dose of 30 mg daily edoxaban, or no anticoagulation treatment. Warfarin dosing will be adjusted according to guidelines from Brazil for patients with low kidney function. The study will follow participants over a median period of 24 months to assess outcomes. During the trial, participants will be monitored regularly to evaluate both the benefits and risks of each treatment strategy. Researchers will measure primary and secondary outcomes related to efficacy and safety, including bleeding and stroke events. Follow-up evaluations will include clinical assessments and laboratory tests to track kidney function and blood clotting status throughout the study duration.

Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)