RecruitingPhase 2NCT05540587

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

A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

Sponsor

Sung-Hwan Kim

Enrollment

240 participants

Start Date

May 20, 2022

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Stroke Mitral Valve Stenosis Systemic Embolism

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.

Eligibility

Min Age: 19 YearsMax Age: 79 Years

Inclusion Criteria3

\< 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 Criteria18

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

Interventions

DRUGEdoxaban

Patients in the Edoxaban group take Edoxaban 60mg once daily. If any of the following conditions are present, take 30mg once daily. * CrCl 15-50mL/min * Body weight ≤ 60kg * Concomitant use of P-glycoprotein inhibitor (Dronearone, Ciclosporine, Erythromycin or Ketoconazole)

DRUGWarfarin

Patients in the Warfarin group take Warfarin 2-10mg once daily, dose adjusted with the target INR 2-3. In the elderly or frail patients, a lower dose administration is allowed at the discretion of the investigator.