drugset / Trial / NCT05540587

Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

NCT05540587

RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to compare the efficacy and safety of the edoxaban and the warfarin in atrial fibrillation patients with mitral stenosis. The study design is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. Primary outcome was a composite of stroke and systemic arterial thromboembolism. The safety outcome was major bleeding.

Timeline

Start
2022-05-20
Primary completion
2024-05-20
Completion
2026-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule 30 mg Oral
Subject Edoxaban Small molecule 60 mg Oral
Comparator Warfarin Small molecule 2 mg Oral
Comparator Warfarin Small molecule 10 mg Oral