NCT00132912已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,030
- 主要终点
- Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
研究概览
简要总结
The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.
A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.
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
- Double
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
- •A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
- •If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.
排除标准
- •Pregnancy
- •Recent stroke
- •Active internal bleeding or a history of a bleeding disorder
- •Increased risk of bleeding
- •Severe high blood pressure
- •Liver or kidney disease
- •Low platelet count
- •Condition such as alcoholism, mental illness, or drug dependence
- •Ongoing chest pain
- •Planned or ongoing treatment with a blood thinning medication
- •A serious condition or illness that would interfere with participation in the study
结局指标
主要结局
Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
次要结局
- Incidence of bleeding throughout treatment and follow-up
- Incidence of death and major adverse cardiac events
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