EUCTR2008-004522-16-IT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) - ND
DAIICHI SANKIO DEVELOPMENT LIMITED0 个研究点目标入组 16,500 人开始时间: 2009年1月20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
- 16,500
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 a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring)consistent with AF (notation of AF as the abnormal rhythm on the local ECG report with evidence of irregularly irregular rhythm and an absence of P-waves on the ECG for diagnosis of AF) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study, including subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous vitamin K antagonist (VKA)(including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
- •4. A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2, is required to be eligible for the study. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
- •1. Male or female subjects with age ≥ 21 years;
- •2. Able to provide written informed consent;
- •3. History of AF documented by a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring)consistent with AF (notation of AF as the abnormal rhythm on the local ECG report with evidence of irregularly irregular rhythm and an absence of P-waves on the ECG for diagnosis of AF) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study, including subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous vitamin K antagonist (VKA)(including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive);
- •4. A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2, is required to be eligible for the study. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Transient AF secondary to other reversible disorders (e.g., thyrotoxicosis, cardiac or thoracic surgery, pneumonia, severe anemia); 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);
- •3. Subjects for whom the AF management plan is rhythm control with subsequent discontinuation of oral anticoagulation if sinus rhythm is restored or maintained, including subjects in whom successful electrical or surgical ablation has been performed or is planned during the course of the study;
- •4. Subjects with any contraindication for anticoagulant agents;
- •5. Subjects with conditions associated with high risk of bleeding such as past history of spontaneous intracranial, 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;
- •6. Subjects receiving thienopyridines (such as ticlopidine or clopidogrel) or other non-aspirin antiplatelet agents that cannot be stopped at randomization, or who are anticipated to receive non-aspirin antiplatelet agents as chronic therapy during the study;
- •1. Transient AF secondary to other reversible disorders (e.g., thyrotoxicosis, cardiac or thoracic surgery, pneumonia, severe anemia); 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);
- •3. Subjects for whom the AF management plan is rhythm control with subsequent discontinuation of oral anticoagulation if sinus rhythm is restored or maintained, including subjects in whom successful electrical or surgical ablation has been performed or is planned during the course of the study;
- •4. Subjects with any contraindication for anticoagulant agents;
- •5. Subjects with conditions associated with high risk of bleeding such as past history of spontaneous intracranial, 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;
- •6. Subjects receiving thienopyridines (such as ticlopidine or clopidogrel) or other non-aspirin antiplatelet agents that cannot be stopped at randomization, or who are anticipated to receive non-aspirin antiplatelet agents as chronic therapy during the study;
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