Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00886509
Status:
COMPLETED
Last Update Posted:
2015-12-16
First Post:
2009-04-22
Brief Title:
Peg-Granulocyte-Colony Stimulating Factor GCSF for Coronary Collateral Growth in Coronary Artery Disease Patients
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg with colony-stimulating factor-therapy in humans The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None