Acute Myocardial Infarction Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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