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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:
ClinicalTrials.gov Identifier:
NCT00215124
First Posted: September 22, 2005
Last Update Posted: September 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Cleveland Clinic
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • 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 ]

Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Acute Myocardial Infarction within 6 hours of symptoms

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215124


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Stephen Ellis, MD The Cleveland Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00215124     History of Changes
Other Study ID Numbers: 5225
First Submitted: September 14, 2005
First Posted: September 22, 2005
Last Update Posted: September 19, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs