Coronary Artery DiseaseNCT00886509
Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients
A study testing pegfilgrastim in people with Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- pegfilgrastim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Berne
Bern, Canton of Bern, 3010
University Hospital Berne
Bern, 3010
About this study
Official title: Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
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.
Read the detailed description
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
- Coronary Artery Disease
- Being tested
- pegfilgrastim, Placebo
- Keywords
- Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegfilgrastimBiological
Also called Peg-GCSF, Peg-G-CSF, PEG-rmetHuG-CSF, Amgen brand of pegfilgrastim
s.c. administration of pegylated G-CSF over 6 months
PlaceboOther
Also called Placebo control
Placebo control Arm 1: Collateral promotion; PCI after 6 months
| Study group | Role | What they receive |
|---|---|---|
| Collateral promotion; PCI after 6 months | Experimental | First pegGCSF or placebo; PCI after 6 months Receives: Biological: pegfilgrastim; Other: Placebo |
| Collateral promotion after PCI at baseline | Experimental | Collateral promotion with pegGCSF after PCI at baseline Receives: Biological: pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collateral flow index (CFI)
Measured: 6 months
Secondary outcomes (1)
Myocardial blood flow (MBF) during hyperemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Seiler, MD, Prof., Study chair, University of BernTobias Traupe, MD, Principal investigator, University Hospital BerneMichael Stoller, MD, Principal investigator, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886509
- Sponsor's protocol ID
- 199/2008
- Status last verified
- Dec 2015
- First submitted
- 22 Apr 2009
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19770393
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00886509
- Acronym / sponsor ID
- 199/2008
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collateral promotion; PCI after 6 months | Experimental | Biological: pegfilgrastim, Other: PlaceboFirst pegGCSF or placebo; PCI after 6 months |
| Collateral promotion after PCI at baseline | Experimental | Biological: pegfilgrastimCollateral promotion with pegGCSF after PCI at baseline |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Acute myocardial infarction
- Unstable CAD
- CAD treated best by CABG
- Patients with overt neoplastic disease
- Patients with diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegfilgrastimAlso: Peg-GCSF, Peg-G-CSF, PEG-rmetHuG-CSF, Amgen brand of pegfilgrastims.c. administration of pegylated G-CSF over 6 months | Biological | Collateral promotion after PCI at baseline, Collateral promotion; PCI after 6 months |
| PlaceboAlso: Placebo controlPlacebo control Arm 1: Collateral promotion; PCI after 6 months | Other | Collateral promotion; PCI after 6 months |
Primary outcome
Collateral flow index (CFI)
Time frame: 6 months
1 secondary outcome
Myocardial blood flow (MBF) during hyperemia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Background: PubMed 19770393Meier 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Seiler, MD, Prof. study chair
University of Bern
Tobias Traupe, MD principal investigator
University Hospital Berne
Michael Stoller, MD principal investigator
University Hospital Berne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegfilgrastim in people with Coronary Artery Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collateral flow index (CFI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00886509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.