EUCTR2008-004522-16-BG进行中（未招募）不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF DU-176B VERSUS WARFARIN IN SUBJECTS WITH ATRIAL FIBRILLATION – Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation (ENGAGE AF - TIMI 48) - ENGAGE AF - TIMI 48
Daiichi Sankyo Pharma Development0 个研究点目标入组 20,500 人开始时间: 2009年2月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20,500
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
- 性别
- All
入选标准
- •1. Male or female subjects with age = 21 years;
- •2. Able to provide written informed consent;
- •3. History of AF documented by any electrical tracing (routine 12-lead electrocardiographic reading [ECG], Holter monitor [continuous ECG recording], rhythm strip, intracardiac electrogram, or pacemaker [PM] or implantable cardiac defibrillator [ICD] interrogation) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study; subjects with AF includes subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous VKA (including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
- •4. Subjects must have a CHADS2 index score of = 2. The CHADS2 scoring is performed by assigning 1 point each for a history of congestive heart failure, hypertension, age = 75 years, or diabetes mellitus; and by assigning 2 points for history of stroke or TIA.
- •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 6150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14350
- •1. Male or female subjects with age = 21 years;
- •2. Able to provide written informed consent;
- •3. History of AF documented by any electrical tracing (routine 12-lead electrocardiographic reading [ECG], Holter monitor [continuous ECG recording], rhythm strip, intracardiac electrogram, or pacemaker [PM] or implantable cardiac defibrillator [ICD] interrogation) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study; subjects with AF includes subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous VKA (including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
- •4. Subjects must have a CHADS2 index score of = 2. The CHADS2 scoring is performed by assigning 1 point each for a history of congestive heart failure, hypertension, age = 75 years, or diabetes mellitus; and by assigning 2 points for history of stroke or TIA.
- •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 6150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14350
排除标准
- •2. Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve (subjects with bioprosthetic heart valves and/or valve repair can be included);
- •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;
- •7. 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 prohibited concomitant medications (fibrinolytics, non-study anticoagulants other than those used as a bridge to/from study drug, chronic oral or parental non-aspirin NSAID (use of NSAIDs via other routes are not restricted) use for = 4 days/week, and potent P-gp inhibitors as defined for this study;
- •22. Subjects with the following diagnoses or situations:
- •Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g., cervical cancer in situ);
- •Treatment with cancer therapy (drug, radiation and/or surgery) within the last 5 years;
- •Significant active concurrent medical illness or infection;
- •Life expectancy < 12 months;
- •2. Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve (subjects with bioprosthetic heart valves and/or valve repair can be included);
- •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;
- •7. 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 prohibited concomitant medications (fibrinolytics, non-study anticoagulants other than those used as a bridge to/from study drug, chronic oral or parental non-aspirin NSAID (use of NSAIDs via other routes are not restricted) use for = 4 days/week, and potent P-gp inhibitors as defined for this study;
- •22. Subjects with the following diagnoses or situations:
- •Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g., cervical cancer in situ);
- •Treatment with cancer therapy (drug, radiation and/or surgery) within the last 5 years;
- •Significant active concurrent medical illness or infection;
- •Life expectancy < 12 months;
研究者
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