Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients

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. Identifier: NCT00886509
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
The purpose of this study in patients with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim, PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Biological: pegfilgrastim Other: Placebo Not Applicable

Detailed Description:
Coronary artery disease (CAD) is the leading cause of death in industrialized countries. Current revascularization therapies are PCI or surgical revascularization. However, inherent to them are procedure-related risks and the fact, that progression of CAD is not prevented. Additionally, up to one fourth of all CAD patients are not amenable to standard revascularization therapies. Thus, there is a need for alternative therapies. The coronary collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality. Coronary collateral growth promotion is an alternative to conventional revascularization which can be achieved by cytokine-based approaches (e.g. with colony-stimulating factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study Start Date : March 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Collateral promotion; PCI after 6 months
First pegGCSF or placebo; PCI after 6 months
Biological: pegfilgrastim
s.c. administration of pegylated G-CSF over 6 months
Other Names:
  • Peg-GCSF
  • Peg-G-CSF
  • PEG-rmetHuG-CSF
  • Amgen brand of pegfilgrastim
  • Neulasta
  • pegylated (r-G-CSF)
Other: Placebo
Placebo control Arm 1: Collateral promotion; PCI after 6 months
Other Name: Placebo control
Experimental: Collateral promotion after PCI at baseline
Collateral promotion with pegGCSF after PCI at baseline
Biological: pegfilgrastim
s.c. administration of pegylated G-CSF over 6 months
Other Names:
  • Peg-GCSF
  • Peg-G-CSF
  • PEG-rmetHuG-CSF
  • Amgen brand of pegfilgrastim
  • Neulasta
  • pegylated (r-G-CSF)

Primary Outcome Measures :
  1. Collateral flow index (CFI) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Myocardial blood flow (MBF) during hyperemia [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 18 years old
  2. 1- to 3-vessel coronary artery disease (CAD)
  3. Stable angina pectoris
  4. At least 1 stenotic lesion suitable for PCI
  5. No Q-wave myocardial infarction in the area undergoing CFI measurement
  6. Written informed consent to participate in the study

Exclusion Criteria:

  1. Acute myocardial infarction
  2. Unstable CAD
  3. CAD treated best by CABG
  4. Patients with overt neoplastic disease
  5. Patients with diabetic retinopathy
  6. Liver or kidney disease
  7. Pre-menopausal women

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 identifier (NCT number): NCT00886509

University Hospital Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Study Chair: Christian Seiler, MD, Prof. University of Bern
Principal Investigator: Tobias Traupe, MD University Hospital Berne
Principal Investigator: Michael Stoller, MD University Hospital Berne

Responsible Party: University Hospital Inselspital, Berne Identifier: NCT00886509     History of Changes
Other Study ID Numbers: 199/2008
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Keywords provided by University Hospital Inselspital, Berne:
Coronary Artery Disease
Coronary Collaterals
Therapeutic Collateral Promotion (TCP)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs