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

Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00886509
Enrollment
50
Registered
2009-04-23
Start date
2009-03-31
Completion date
2015-02-28
Last updated
2015-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)

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.

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.

Interventions

BIOLOGICALpegfilgrastim

s.c. administration of pegylated G-CSF over 6 months

OTHERPlacebo

Placebo control Arm 1: Collateral promotion; PCI after 6 months

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
Collateral flow index (CFI)6 months

Secondary

MeasureTime frame
Myocardial blood flow (MBF) during hyperemia6 months

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026