Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days
研究概览
简要总结
The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction.
The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized.
It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will be 2:1 randomization with 9 patients total.
Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo.
Primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days.
9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.
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
- Single
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 Myocardial Infarction within 6 hours of symptoms
排除标准
- 未提供
结局指标
主要结局
Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days
时间窗: 30 days
次要结局
- i) Survival through 12 months ii) Re-hospitalization for CHF through 12 months iii) Improvement in LVEF at days 7 and 12 months iv) Infarct wall thickness at 30 days v) Re-infarction within 30 days v(specified above)