EUCTR2013-003148-21-GB进行中（未招募）1 期
A prospective, randomised, open-label, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU-176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation - ENSURE in AF
Daiichi Sankyo Development Ltd0 个研究点目标入组 2,199 人开始时间: 2014年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,199
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Signed ICF;
- •2. Male or female subjects older than the minimum legal adult age (country specific);
- •3. Ongoing AF lasting for at least 48 hours but = 12 months;
- •Ongoing AF at the time of randomization should be confirmed by any electrical tracing (eg, routine 12-lead electrocardiogram (ECG), Holter monitor rhythm strip, intracardiac electrogram, or pacemaker) prior to randomization. Duration and proof of AF during the previous 12 months can be confirmed by any electrical tracing or a recording in the subject’s medical records (eg, medical chart, hospital discharge summary);
- •4. Subject is planned for electrical cardioversion;
- •Subjects with AF following a cardiac surgical procedure will be allowed in the study providing that they meet all the other inclusion criteria AND the time from the surgery to randomization is no less than 30 days. The Investigator will be responsible for assessment of risks relevant to the cardioversion procedure in such subjects.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 660
排除标准
- •1. AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery [unless the duration of AF post-cardiac surgery is > 30 days, refer to inclusion criterion #4], ionic disturbances, thyrotoxicosis, pneumonia, severe anemia, etc);
- •2. No evidence of rhythm other than AF on any ECG or any other available recording (including patient’s notes) for more than 12 consecutive months prior to randomization;
- •3. Subjects with moderate or severe mitral stenosis, mitral valve rheumatic disease, unresected atrial myxoma, or a mechanical heart valve (subjects with bioprosthetic heart valves and/or valve repair can be included) and/or other conditions, such as PE, considered to be formal indication for conventional anticoagulation;
- •a. However subjects with AF and valvular heart diseases such as mitral valve prolapse, mitral valve regurgitation, and aortic valve disease are allowed in the study;
- •4. Subjects with a history of LAA closure (either by surgery or by a procedure);
- •5. Known presence of a thrombus in LAA, LA, left ventricle, aorta or intracardial mass;
- •6. Subjects with acute myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention within the previous 30 days or receiving DAPT regardless of when the event has occurred;
- •7. Subjects with any contraindication to anticoagulant agents;
- •8. Signs of bleeding or conditions associated with high risk of bleeding including major surgeries or biopsies in the last 10 days;
- •9. Subjects with conditions associated with high risk of bleeding such as past history of intracranial (spontaneous or traumatic), or spontaneous intraocular, spinal, retroperitoneal, or intra-articular bleeding; overt gastrointestinal (GI) bleeding or active ulcer within the previous year; recent severe trauma, major surgery, or deep organ biopsy within the previous 10 days; active infective endocarditis; uncontrolled hypertension (blood pressure [BP] above 170/100 mmHg); or hemorrhagic disorder including known or suspected hereditary or acquired bleeding or coagulation disorder;
- •10. Subjects receiving dual antiplatelet therapy (eg, aspirin plus thienopyridine such as clopidogrel, prasugrel or ticagrelor) or anticipated to receive such therapy;
- •11. Subjects receiving prohibited concomitant medications (fibrinolytics, non-study anticoagulants other than those used as a bridge to/from study drug), chronic oral or parenteral Non-Aspirin/Non-Steroidal Anti-Inflammatory Drugs (NSAID) use for = 4 days/week;
- •12. Subjects receiving chronic cyclosporine therapy;
- •13. Subjects with active liver disease or persistent (confirmed by repeat assessments at least a week apart) elevation of liver enzymes/bilirubin:
- •ALT or AST = 2 x ULN;
- •TBL = 1.5 x ULN (however, subjects whose elevated TBL is due to known Gilbert’s syndrome may be included in the study);
- •14. Subjects with renal failure (end stage renal disease, calculated CrCL < 15 mL/min);
- •15. Subjects with hemoglobin < 10 g/dL or platelet count < 100000 cells/mcL or white blood cell count < 3000 cells/mcL;
- •16. Subjects with pre-planned invasive procedures (other than routine endoscopy) or surgeries in which ble
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