drugset / Trial / NCT05540587
Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |