NCT00935506已完成1 期
Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
研究概览
简要总结
Purpose of study is to evaluate a thrombosis chamber model
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects
- •BMI 18-30 kg/m²
- •Male ages 18-45
排除标准
- •Significant acute or chronic illness
- •History of abnormal bleeding or coagulation disorder, intracranial hemorrhage, or a family history of abnormal bleeding or coagulation disorder in a first degree relative under 50 years of age
- •Easy bruising
- •Smoking within 3 months prior to Day 1
研究组 & 干预措施
Clopidogrel + Aspirin
Experimental
干预措施: Clopidogrel (Drug)
Clopidogrel + Aspirin
Experimental
干预措施: Aspirin (Drug)
结局指标
主要结局
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
时间窗: Period 2, Day 8
次要结局
- Assess relationship between platelet aggregation and thrombus formation(Period 1 and Period 2)
- Assess variability of thrombosis chamber measurements(Period 1 and Period 2)
- Safety and tolerability of multiple doses clopidogrel and aspirin(From Day 1 through Study Discharge)
研究者
研究点 (1)
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