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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00886509
First received: April 22, 2009
Last updated: December 15, 2015
Last verified: December 2015
  Purpose
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 Intervention
Coronary Artery Disease
Biological: pegfilgrastim
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Collateral flow index (CFI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Myocardial blood flow (MBF) during hyperemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2009
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886509

Locations
Switzerland
University Hospital Berne
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00886509     History of Changes
Other Study ID Numbers: 199/2008 
Study First Received: April 22, 2009
Last Updated: December 15, 2015
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on May 01, 2016