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

• Status: Recruiting
• Trial end date: 2026-05-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sung-Hwan Kim
• Collaborator: Daiichi Sankyo Korea Co., Ltd.
• Treatments: Edoxaban; Warfarin

Criteria

• Inclusion criteria

• 18 < Age < 80

• AF diagnosed by ECG at any time prior to enrollment

• Moderate or severe mitral valve stenosis diagnosed by echocardiography at any time prior to enrollment

• Exclusion criteria

• Refusal to consent

• Transient AF due to reversible cause (Postoperative, ongoing systemic inflammation, thyrotoxicosis)

• Patients undergoing mechanical valve replacement

• Coagulopathy

• Hepatic impairment with significant bleeding risk

• High bleeding risk due to following disease or condition diagnosed within 1 month prior to randomization

• GI ulcer or bleeding, Esophageal or gastric varix, Malignancy, Brain or cord injury, Surgery for brain, spinal cord, opthalmic, Intracranial hemorrhage, Arteriovenous malformation, Vascular aneurysms, Brain or spinal vascular disorder

• Stroke, Systemic arterial thromboembolism, Acute myocardial infarction diagnosed within 14 days prior to randomization

• End stage kidney disease (CrCL < 15mL/min) or Dialysis

• Severe hypertension

• Alcohol abuse or other psychiatric disease

• Epidural puncture or anesthesia

• Pulmonary thromboembolism with hemodynamical instability requiring thrombolysis or thrombectomy

• Pregnant or lactating women

• Allergy to edoxaban or warfarin

• Ongoing need for other anticoagulant or clarithromycin, rifampin)

• Participants for other trials within 1 month prior to enrollment

• Other patients to be inappropriate to participate in the trial determined by the investigator