Clinical Trials

Toll-Free: 866.320.4573

Call Us Toll Free:

866.223.2273 x1234

A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Study:

Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Rationale:

n/a

Purpose:

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 Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Acute Myocardial Infarction Drug: Filgrastim Phase 1/Phase 2

Verified by The Cleveland Clinic September, 2008

Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT00215124

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Stephen Ellis, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

Cleveland Clinic Mobile Site