NCT00123565已完成2 期
A Randomized Dose Ranging Study of Hexadecasaccharide Including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention (SHINE)
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
- 1,257
- 试验地点
- 20
- 主要终点
- Efficacy: composite of all causes of death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization.
研究概览
简要总结
The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person with a diagnosis of acute coronary syndrome who is scheduled to undergo a PCI within 48 hours.
- •A person who is of the legal age of 21, who is mentally competent, and who has signed a written informed consent
排除标准
- •A person with known allergy or any contra-indication to active control.
- •A person who has received heparin during more than 48 hours before inclusion in the study.
- •A person treated with warfarin (oral anticoagulant).
- •A person with current bleeding or recognized increased risk of bleeding or history of intracranial hemorrhage.
- •A person who has had a stroke within the last 6 months.
- •A person with uncontrolled hypertension despite antihypertensive therapy.
- •A person with history of clinically significant reduction in blood platelets or neutrophils (white blood cells).
- •A person who has laboratory evidence of significantly reduced renal function or who is dependent on renal dialysis.
- •A person who has a coronary bypass performed during the previous month.
- •A pregnant or nursing woman or a woman of childbearing potential (before menopause) who does not have a negative pregnancy test and does not use a reliable method of birth control.
- •A person who has received any investigational treatment in the preceding month.
结局指标
主要结局
Efficacy: composite of all causes of death, new myocardial infarction, or severe myocardial ischemia requiring urgent repeat target vessel revascularization within 7 days following randomization.
次要结局
- Safety: Major bleeding according to the criteria of Thrombolysis In Myocardial Infarction study group.
研究者
研究点 (20)
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