NCT00619164已完成2 期
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •45 - 80 years old (at time of informed consent)
- •Male or female (females of childbearing potential must be contracepted)
- •Confirmed acute coronary syndrome
排除标准
- •Unwilling or unable to provide informed consent
- •History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder
- •Recent trauma or major surgery
- •Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening
- •History of intracranial bleeding or history of hemorrhagic retinopathy
- •History of New York Heart Association (NYHA) class III or IV congestive heart failure
- •Pregnant or lactating women
研究组 & 干预措施
1
Experimental
干预措施: E5555 (Drug)
2
Experimental
干预措施: E5555 (Drug)
3
Experimental
干预措施: E5555 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG.
时间窗: 3 months
次要结局
- Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration.(3 months)
研究者
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