Filgrastim for the Promotion of Collateral Growth in Patients With CAD

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Drug: Filgrastim (rG-CSF)

Study type: Interventional

Funder types: Other

Identifiers

NCT00596479

05/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind