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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Biological: pegfilgrastim; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00886509

199/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Collateral promotion; PCI after 6 months

Experimental group

Description:

First pegGCSF or placebo; PCI after 6 months

Treatment:

Other: Placebo

Biological: pegfilgrastim

Collateral promotion after PCI at baseline

Experimental group

Description:

Collateral promotion with pegGCSF after PCI at baseline

Treatment:

Biological: pegfilgrastim