NCT00103350已完成1 期
A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Prospective Study to Evaluate the Safety and Potential Efficacy of Single, Increasing Doses of TG100-115 in Subjects Undergoing Percutaneous Coronary Intervention for Acute Anterior ST Elevation Myocardial Infarction
TargeGen2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety and pharmacokinetics of TG100-115
研究概览
简要总结
TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis of this study is that TG100-115 can be given safely to patients who suffer a heart attack and undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces heart muscle damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 yrs
- •ECG patterns consistent with an acute anterior myocardial infarction with ST segment elevation of 2mm in two contiguous ECG leads among leads V1-V
- •Have prolonged, continuous (lasting at least 20 mins) signs and symptoms of myocardial ischemia not eliminated with nitrates.
- •Intent to proceed to primary PCI within 6 hours of chest pain onset
- •Sign an informed consent form and be willing to attend follow-up visits for safety and other study assessments.
排除标准
- •Female of childbearing potential.
- •History of previous myocardial infarction.
- •History of congestive heart failure.
- •Requirement for a cardiac pacemaker or defibrillator.
- •Cardiogenic shock.
- •Patients previously treated with thrombolytic therapy.
- •Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease.
结局指标
主要结局
Safety and pharmacokinetics of TG100-115
次要结局
- Impact of TG100-115 on infarct size
研究者
研究点 (2)
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