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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Biological: pegfilgrastim; Other: Placebo

• Registration Number: NCT00886509
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collateral promotion; PCI after 6 months	Placebo	First pegGCSF or placebo; PCI after 6 months
Collateral promotion; PCI after 6 months	pegfilgrastim	First pegGCSF or placebo; PCI after 6 months
Collateral promotion after PCI at baseline	pegfilgrastim	Collateral promotion with pegGCSF after PCI at baseline

Primary Outcome Measures

Name	Time	Method
Collateral flow index (CFI)	6 months

Secondary Outcome Measures

Name	Time	Method
Myocardial blood flow (MBF) during hyperemia	6 months

Trial Locations

Locations (1)

University Hospital Berne; 🇨🇭 Berne, Switzerland