Atrial Fibrillation, Mitral Valve Stenosis, Stroke, Systemic Embolism
Conditions
Keywords
Edoxaban, Warfarin, Stroke, Systemic embolism, Mitral Valve Stenosis, Atrial Fibrillation
Brief 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.
Detailed description
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.
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.
Sponsors
Daiichi Sankyo Korea Co., Ltd.
Sung-Hwan Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Stroke or Systemic arterial thromboembolism | 15 days after randomization | The number of patients with the first occurrence of a stroke or systemic embolism during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 15 days after randomization | The number of patients with the first occurrence of a stroke during the study period |
| Systemic embolism | 15 days after randomization | The number of patients with the first occurrence of a systemic embolism during the study period |
| Death from any cause | 15 days after randomization | The number of patients who died for any reason during the study period |
Countries
South Korea
Contacts
Primary ContactSung hwan Kim, MD, PhD
Outcome results
None listed