drugset / Trial / NCT02561897

EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation

NCT02561897

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.

Timeline

Start
2015-12
Primary completion
2017-09
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule 30 mg
Subject Edoxaban Small molecule 60 mg
Comparator Warfarin Small molecule

Indications