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

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

* 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

Conditions5

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