Filgrastim for the Promotion of Collateral Growth in Patients With CAD

Coronary Artery Disease Clinical Trial

Official title:

Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596479
• Other study ID #: 05/04
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: June 15, 2015
• Start date: November 2004
• Est. completion date: December 2007

Study information

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

Clinical Trial Summary

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.

Description:

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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:

• Patients admitted as emergencies

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Filgrastim (rG-CSF)

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Swiss Heart Foundation, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
Secondary	Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up