NCT00886509

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

5.9 years

First QC Date

April 22, 2009

Last Update Submit

December 15, 2015

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseStableCoronary CollateralsTherapeutic Collateral Promotion (TCP)

Outcome Measures

Primary Outcomes (1)

  • Collateral flow index (CFI)

    6 months

Secondary Outcomes (1)

  • Myocardial blood flow (MBF) during hyperemia

    6 months

Study Arms (2)

Collateral promotion; PCI after 6 months

EXPERIMENTAL

First pegGCSF or placebo; PCI after 6 months

Biological: pegfilgrastimOther: Placebo

Collateral promotion after PCI at baseline

EXPERIMENTAL

Collateral promotion with pegGCSF after PCI at baseline

Biological: pegfilgrastim

Interventions

pegfilgrastimBIOLOGICAL

s.c. administration of pegylated G-CSF over 6 months

Also known as: Peg-GCSF, Peg-G-CSF, PEG-rmetHuG-CSF, Amgen brand of pegfilgrastim, Neulasta, pegylated (r-G-CSF)
Collateral promotion after PCI at baselineCollateral promotion; PCI after 6 months
PlaceboOTHER

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

Also known as: Placebo control
Collateral promotion; PCI after 6 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Berne

Bern, Canton of Bern, 3010, Switzerland

Location

University Hospital Berne

Bern, 3010, Switzerland

Location

Related 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.

    PMID: 19770393BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

pegfilgrastimpegylated granulocyte colony-stimulating factor, human

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Christian Seiler, MD, Prof.

    University of Bern

    STUDY CHAIR

  • Tobias Traupe, MD

    University Hospital Berne

    PRINCIPAL INVESTIGATOR

  • Michael Stoller, MD

    University Hospital Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

March 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

CH(2)