CTRI/2009/091/000201已完成3 期
A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14,266
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria:
- •* Male and female patients 18 years of age or older
- •* Subjects must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
- •* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, OR at least two of the following risk factors:
- •* Heart failure
- •* Hypertension
- •* Age 75 years or greater
- •* Diabetes mellitus
排除标准
- •Exclusion Criteria:
- •* Significant mitral stenosis
- •* Transient atrial fibrillation caused by a reversible disorder
- •* Active internal bleeding
- •* Severe disabling stroke
- •* History of intracranial bleeding
- •* Hemorrhagic disorders
研究者
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