NCT00942435已完成3 期
A Randomized, Open Label Parallel Group Mechanical Prophylaxis Controlled Comparison Study With YM150, a Direct Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 主要终点
- Composite assessment of venous thromboembolism events and all causes of death
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after a major abdominal surgery
- •Written informed consent obtained
排除标准
- •Subject has history of symptomatic deep vein thrombosis and/or pulmonary embolism
- •Subject has a hemorrhagic disorder and/or coagulation disorder
- •Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
- •Subject has an active bacterial endocarditis
- •Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
- •Subject is receiving anticoagulants/antiplatelet agents
- •Subject has a thrombocytopenia
- •Body weight less than 40 kg at the screening
研究组 & 干预措施
YM150 group
Experimental
干预措施: YM150 (Drug)
mechanical prophylaxis group
Active Comparator
干预措施: mechanical prophylaxis (Procedure)
结局指标
主要结局
Composite assessment of venous thromboembolism events and all causes of death
时间窗: Until day 12
次要结局
- Incidence of venous thromboembolism(Until day 28)
- Incidence of bleeding events(Until day 28)
- All cause mortality(Until day 28)
研究者
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