Stroke Clinical Trial
— ERTEMISOfficial title:
A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | May 20, 2026 |
Est. primary completion date | May 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 79 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Bucheon St. Mary's hospital | Bucheon | |
Korea, Republic of | Daejeon St. Mary's hospital | Daejeon | |
Korea, Republic of | Incheon St. Mary's hospital | Incheon | |
Korea, Republic of | Seoul St. Mary's Hospital | Seoul | Seocho-gu |
Korea, Republic of | St. Vincent hospital | Suwon | |
Korea, Republic of | Uijeongbu St. Mary's Hospital | Uijeongbu | |
Korea, Republic of | Yeouido St. Mary's hospital | Yeongdeungpo-gu | Seoul |
Lead Sponsor | Collaborator |
---|---|
Sung-Hwan Kim | Daiichi Sankyo Korea Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of Stroke or Systemic arterial thromboembolism | The number of patients with the first occurrence of a stroke or systemic embolism during the study period | 15 days after randomization | |
Secondary | Stroke | The number of patients with the first occurrence of a stroke during the study period | 15 days after randomization | |
Secondary | Systemic embolism | The number of patients with the first occurrence of a systemic embolism during the study period | 15 days after randomization | |
Secondary | Death from any cause | The number of patients who died for any reason during the study period | 15 days after randomization |
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