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.
Non-vitamin K antagonist oral anticoagulants (NOACs) are generally recommended as 1st line therapy for oral anticoagulant in patients with atrial fibrillation (AF). But, the efficacy and safety of NOAC in AF patients with prosthetic mechanical heart valves or moderate to severe mitral valve stenosis have not been proven, and the guidelines recommend vitamin K antagonist (VKA) administration to those patient groups. This trial aims to compare the efficacy and safety of the edoxaban and the warfarin in AF patients with moderate to severe mitral valve stenosis. Edoxaban in patients with aTrial fibrillation and MItral Stenosis (ERTEMIS) trial is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. The primary efficacy outcome is a composite of stroke and systemic arterial thromboembolism. The secondary efficacy outcomes are each component of the primary efficacy outcomes and death from any cause. The safety outcome was major bleeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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)
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.
Seoul St. Mary's Hospital
Seoul, Seocho-gu, South Korea
RECRUITINGYeouido St. Mary's hospital
Yeongdeungpo-gu, Seoul, South Korea
RECRUITINGBucheon St. Mary's hospital
Bucheon-si, South Korea
RECRUITINGDaejeon St. Mary's hospital
Daejeon, South Korea
RECRUITINGIncheon St. Mary's hospital
Incheon, South Korea
RECRUITINGSt. Vincent hospital
Suwon, South Korea
RECRUITINGUijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
RECRUITINGComposite of Stroke or Systemic arterial thromboembolism
The number of patients with the first occurrence of a stroke or systemic embolism during the study period
Time frame: 15 days after randomization
Stroke
The number of patients with the first occurrence of a stroke during the study period
Time frame: 15 days after randomization
Systemic embolism
The number of patients with the first occurrence of a systemic embolism during the study period
Time frame: 15 days after randomization
Death from any cause
The number of patients who died for any reason during the study period
Time frame: 15 days after randomization
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