ACTRN12609000132246招募中3 期
A phase 3, randomised, 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
Daiichi Sankyo Pharma Development0 个研究点目标入组 16,500 人开始时间: 2009年2月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 21 Years 至 o limit（—）
- 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 Atrial Fibrillation (AF) documented by a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring) consistent with Atrial Fibrillation (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 Scoring system Congestive Heart Failure, Hypertension, Age, Diabetes, previous stroke (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 Trans Ischemic Attack (TIA).
排除标准
- •1Transient AF secondary to other reversible disorders
- •2Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
- •3Subjects with any contraindication for anticoagulant agents;
- •4Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
- •5Females of childbearing potential including the following:
- •a)Females with a history of
- •tubal-ligation;
- •b) Females less than 2 years
- •post-menopausal
研究者
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