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Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients

NCT ID: NCT00886509

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Coronary artery disease (CAD) is the leading cause of death in industrialized countries. Current revascularization therapies are PCI or surgical revascularization. However, inherent to them are procedure-related risks and the fact, that progression of CAD is not prevented. Additionally, up to one fourth of all CAD patients are not amenable to standard revascularization therapies. Thus, there is a need for alternative therapies. The coronary collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality. Coronary collateral growth promotion is an alternative to conventional revascularization which can be achieved by cytokine-based approaches (e.g. with colony-stimulating factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion.

Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Disease Stable Coronary Collaterals Therapeutic Collateral Promotion (TCP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Collateral promotion; PCI after 6 months

First pegGCSF or placebo; PCI after 6 months

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type OTHER

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

Collateral promotion after PCI at baseline

Collateral promotion with pegGCSF after PCI at baseline

Group Type EXPERIMENTAL

pegfilgrastim

Intervention Type BIOLOGICAL

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

Interventions

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pegfilgrastim

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Peg-GCSF Peg-G-CSF PEG-rmetHuG-CSF Amgen brand of pegfilgrastim Neulasta pegylated (r-G-CSF) Placebo control

Eligibility Criteria

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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

Exclusion Criteria

1. Acute myocardial infarction
2. Unstable CAD
3. CAD treated best by CABG
4. Patients with overt neoplastic disease
5. Patients with diabetic retinopathy
6. Liver or kidney disease
7. Pre-menopausal women
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Seiler, MD, Prof.

Role: STUDY_CHAIR

University of Bern

Tobias Traupe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Berne

Michael Stoller, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Berne

Locations

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University Hospital Berne

Bern, Canton of Bern, Switzerland

Site Status

University Hospital Berne

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 19770393 (View on PubMed)

Other Identifiers

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199/2008

Identifier Type: -

Identifier Source: org_study_id