NCT00133731已完成2 期
A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban (XRP0673), in Comparison to Intravenous Unfractionated Heparin, in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 947
- 试验地点
- 176
- 主要终点
- Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
研究概览
简要总结
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability, clinical efficacy and pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Due to undergo non-urgent percutaneous coronary intervention (PCI)
- •Planned treatment with aspirin and clopidogrel
排除标准
- •Recent acute coronary syndrome
- •Patients at risk for, or with prior recent, bleeding
- •Patients have received recent prior treatment with an anticoagulant
- •Creatinine clearance > 30 ml/min
结局指标
主要结局
Death, myocardial infarction, and urgent and non-urgent target vessel revascularization
次要结局
- Bleeding events
研究者
研究点 (176)
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