Subcutanoeus Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients with Coroanry Artery Disease (FILCAD) - FILCAD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003784-68-SE

Enrollment

Registered

2004-11-10

Start date

2005-04-05

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Coronary Artery Disease

Interventions

Trade Name: Neupogen Product Name: Neupogen Pharmaceutical Form: Cutaneous liquid INN or Proposed INN: Filgrastim Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients admitted as emergencies 2. Acute myocardial infarction 3. Unstable CAD 4. CAD treated best by CABG 5. Severe valve disease 6. Patients with overt neoplastic disease 7. Patients with diabetic retinopathy 8. Overt liver disease 9. Renal insufficiency (creatinine level > 200 µmol/L) or other overt renal disease 10. Pre-menopausal women

Design outcomes

Primary

Measure	Time frame
Main Objective: Prospective, randomised, double-blind, placebo-controlled study with baseline and follow-up measurements of collateral flow (i.e. each patient is his/her own control subject in addition to the placebo-control providing intergroup comparison). Study population Sixty patients with stable coronary artery disease treatable by PCI. G-CSF group: Thirty patients receiving subcutaneous recombinant G-CSF 10 ug/kg body weight every other day during a period of 14 days. Control group: Thirty patients receiving subcutaneous injections of a corresponding volume of NaCl 0.9% (placebo) every other day during a period of 14 days. ;Secondary Objective: ;Primary end point(s): Primary endpoint Subcutaneous delivery of G-CSF in patients with stable 1- to 3-vessel CAD improves collateral flow, i.e., there is a significant increase in CFI during follow-up among patients treated with G-CSF, and the verum group shows a significant augmentation of CFI in comparison to the placebo group. Secondary endpoints 1. Subcutaneous delivery of G-CSF in patients with stable 1- to 3-vessel CAD is safe 2. There is a significant increase in absolute myocardial perfusion during hyperaemia assessed by myocardial contrast echocardiography using adenosine in the region supplied by the stenotic vessel in patients treated with G-CSF compared to placebo after 2 weeks and 6 months.	—

Measure

Time frame

Main Objective: Prospective, randomised, double-blind, placebo-controlled study with baseline and follow-up measurements of collateral flow (i.e. each patient is his/her own control subject in addition to the placebo-control providing intergroup comparison). Study population Sixty patients with stable coronary artery disease treatable by PCI. G-CSF group: Thirty patients receiving subcutaneous recombinant G-CSF 10 ug/kg body weight every other day during a period of 14 days. Control group: Thirty patients receiving subcutaneous injections of a corresponding volume of NaCl 0.9% (placebo) every other day during a period of 14 days. ;Secondary Objective: ;Primary end point(s): Primary endpoint Subcutaneous delivery of G-CSF in patients with stable 1- to 3-vessel CAD improves collateral flow, i.e., there is a significant increase in CFI during follow-up among patients treated with G-CSF, and the verum group shows a significant augmentation of CFI in comparison to the placebo group. Secondary endpoints 1. Subcutaneous delivery of G-CSF in patients with stable 1- to 3-vessel CAD is safe 2. There is a significant increase in absolute myocardial perfusion during hyperaemia assessed by myocardial contrast echocardiography using adenosine in the region supplied by the stenotic vessel in patients treated with G-CSF compared to placebo after 2 weeks and 6 months.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026