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Filgrastim for the Promotion of Collateral Growth in Patients With CAD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00596479
Enrollment
50
Registered
2008-01-17
Start date
2004-11-30
Completion date
2007-12-31
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

CAD, G-CSF, Collaterals, CFI, perfusion

Brief 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.

Detailed 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.

Interventions

DRUGFilgrastim (rG-CSF)

Sponsors

Swiss National Science Foundation
CollaboratorOTHER
Swiss Heart Foundation
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI—

Secondary

MeasureTime frame
Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026