Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients
December 15, 2015 updated by: University Hospital Inselspital, Berne
Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berne, Switzerland, 3010
- University Hospital Berne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18 years old
- 1- to 3-vessel coronary artery disease (CAD)
- Stable angina pectoris
- At least 1 stenotic lesion suitable for PCI
- No Q-wave myocardial infarction in the area undergoing CFI measurement
- Written informed consent to participate in the study
Exclusion Criteria:
- Acute myocardial infarction
- Unstable CAD
- CAD treated best by CABG
- Patients with overt neoplastic disease
- Patients with diabetic retinopathy
- Liver or kidney disease
- Pre-menopausal women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Collateral promotion; PCI after 6 months
First pegGCSF or placebo; PCI after 6 months
|
s.c.
administration of pegylated G-CSF over 6 months
Other Names:
Placebo control Arm 1: Collateral promotion; PCI after 6 months
Other Names:
|
|
Experimental: Collateral promotion after PCI at baseline
Collateral promotion with pegGCSF after PCI at baseline
|
s.c.
administration of pegylated G-CSF over 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Collateral flow index (CFI)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Myocardial blood flow (MBF) during hyperemia
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tobias Traupe, MD, University Hospital Berne
- Principal Investigator: Michael Stoller, MD, University Hospital Berne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
April 22, 2009
First Submitted That Met QC Criteria
April 22, 2009
First Posted (Estimate)
April 23, 2009
Study Record Updates
Last Update Posted (Estimate)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 15, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.