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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886509
• Other study ID #: 199/2008
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: December 15, 2015
• Start date: March 2009
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Biological:
• pegfilgrastim
s.c. administration of pegylated G-CSF over 6 months

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

Locations

Country	Name	City	State
Switzerland	University Hospital Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Meier P, Gloekler S, de Marchi SF, Indermuehle A, Rutz T, Traupe T, Steck H, Vogel R, Seiler C. Myocardial salvage through coronary collateral growth by granulocyte colony-stimulating factor in chronic coronary artery disease: a controlled randomized trial. Circulation. 2009 Oct 6;120(14):1355-63. doi: 10.1161/CIRCULATIONAHA.109.866269. Epub 2009 Sep 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collateral flow index (CFI)		6 months	Yes
Secondary	Myocardial blood flow (MBF) during hyperemia		6 months	No

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