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

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00215124
First received: September 14, 2005
Last updated: September 17, 2008
Last verified: September 2008

September 14, 2005
September 17, 2008
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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 ]
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Complete list of historical versions of study NCT00215124 on ClinicalTrials.gov Archive Site
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 ]
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A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
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.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Acute Myocardial Infarction
Drug: Filgrastim
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Ellis SG, Penn MS, Bolwell B, Garcia M, Chacko M, Wang T, Brezina KJ, McConnell G, Topol EJ. Granulocyte colony stimulating factor in patients with large acute myocardial infarction: results of a pilot dose-escalation randomized trial. Am Heart J. 2006 Dec;152(6):1051.e9-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2007
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Inclusion Criteria:

Acute Myocardial Infarction within 6 hours of symptoms

Exclusion Criteria:

-

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00215124
5225
Yes
Not Provided
The Cleveland Clinic
Not Provided
Principal Investigator: Stephen Ellis, MD The Cleveland Clinic
The Cleveland Clinic
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP