A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction|
- Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: specified above ] [ Designated as safety issue: Yes ]
|Study Completion Date:||February 2007|