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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215124
• Other study ID #: 5225
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 14, 2005
• Last updated: September 17, 2008
• Est. completion date: February 2007

Study information

• Verified date: September 2008
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Acute Myocardial Infarction within 6 hours of symptoms

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Filgrastim

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days		30 days	Yes
Secondary	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	Yes