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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
Christian Seiler, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00886509
First received: April 22, 2009
Last updated: June 17, 2013
Last verified: June 2013
  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 ]

Estimated Enrollment: 75
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Contacts
Contact: Tobias Traupe, MD +41 31 632 ext 4342 tobias.traupe@insel.ch
Contact: Christian Seiler, MD, Prof. +41 31 632 ext 2111 christian.seiler@insel.ch

Locations
Switzerland
University Hospital Berne Recruiting
Berne, Switzerland, 3010
Contact: Michael Stoller    +41 31 632 ext 8030    michael.stoller@insel.ch   
Contact: Christian Seiler, MD, Prof.    +41 31 632 ext 2111    christian.seiler@insel.ch   
Principal Investigator: Christian Seiler, MD, Prof.         
University Hospital Berne Recruiting
Berne, Switzerland, 3010
Contact: Tobias Traupe, MD    +41 31 632 ext 2111    tobias.traupe@insel.ch   
Contact: Christian Seiler, MD, Prof.    +41 31 632 ext 2111    christian.seiler@insel.ch   
Principal Investigator: Christian Seiler, MD, Prof.         
Principal Investigator: de Marchi Stefano, MD         
Principal Investigator: Tobias Traupe, MD         
Sub-Investigator: Rolf Vogel, MD, Prof.         
Sub-Investigator: Ahmed Khattab, MD         
Principal Investigator: Michael Stoller         
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

Publications:
Responsible Party: Christian Seiler, Prof Dr med, 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: June 17, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014