NCT00091637已完成3 期
APEX-AMI - Pexelizumab in Conjunction With Angioplasty
Procter and Gamble343 个研究点 分布在 1 个国家目标入组 5,745 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,745
- 试验地点
- 343
- 主要终点
- Reduction of all causes of mortality
研究概览
简要总结
In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac symptoms for at least 20 minutes within past 6 hours;
- •Will undergo primary PCI;
- •Has ECG evidence of acute high risk ST elevation myocardial infarction;
- •Willing and able to be followed for at least 12 months.
排除标准
- •Isolated low risk inferior wall myocardial infarction;
- •Received fibrinolytic therapy;
- •History of complement deficiency;
- •Suspected neisserial infection;
- •Participating in other investigational study;
- •Pregnancy;
- •Previous enrollment.
研究组 & 干预措施
1
Placebo Comparator
Placebo infusion
干预措施: Placebo infusion (Drug)
2
Experimental
Pexelizumab infusion
干预措施: Pexelizumab (Drug)
结局指标
主要结局
Reduction of all causes of mortality
时间窗: day 30
次要结局
未报告次要终点
研究者
研究点 (343)
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