NCT02770664Unknown2 期
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- AUC of Troponin I for 72 hours post PCI
研究概览
简要总结
Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI).
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 75
- •Within 12 hours after the onset of chest pain
- •ST-segment elevation of more than 0.1 mV in two contiguous leads or new left bundle-branch block (LBBB) patients
- •Signed for written informed consent
排除标准
- •Left Main disease
- •Multi-vessel disease
研究组 & 干预措施
LC28-0126 Dose A
Experimental
干预措施: LC28-0126 Dose A (Drug)
LC28-0126 Dose B
Experimental
干预措施: LC28-0126 Dose B (Drug)
LC28-0126 Dose C
Experimental
干预措施: LC28-0126 Dose C (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
AUC of Troponin I for 72 hours post PCI
时间窗: pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h
次要结局
- Myocardial function assessed by Cardiac MRI(Day 4, 30)
- Myocardial function assessed by Echocardiogram(Day 4, 30)
- Infarct size assessed by Cardiac MRI(Day 4, 30)
- AUC of CK for 72 hours post PCI(pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h)
- AUC of CK-MB for 72 hours post PCI(pre PCI, PCI 0h, 6h, 12h, 18h, 24h, 48h, 72h)
研究者
研究点 (1)
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