NCT00785954已完成2 期
Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
KAI Pharmaceuticals0 个研究点目标入组 1,180 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,180
- 主要终点
- The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
研究概览
简要总结
The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI and has a planned emergent primary PCI procedure
- •Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset
排除标准
- •Persistent systolic blood pressure < 90 mm Hg
研究组 & 干预措施
A3: KAI-9803
Experimental
干预措施: KAI-9803 (Drug)
A1: KAI-9803
Experimental
干预措施: KAI-9803 (Drug)
A2: KAI-9803
Experimental
干预措施: KAI-9803 (Drug)
A4: Placebo
Placebo Comparator
干预措施: KAI-9803 (Drug)
结局指标
主要结局
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
时间窗: During the index hospitalization
次要结局
- The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias(Within the first 3 months after Myocardial Infarction)
- The safety and tolerability of KAI-9803 by IV infusion to acute STEMI(Within the first 3 months after Myocardial Infarction)
- Assess left ventricular function by imaging(Within the first 3 months after Myocardial Infarction)
研究者
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