Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042081
Status:
COMPLETED
Last Update Posted:
2006-05-05
First Post:
2002-07-22
Brief Title:
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
Sponsor:
Anesiva Inc
Organization:
Anesiva Inc
Study Overview
Official Title:
A Phase III Multi-Center Randomized Double-Blind Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Coronary Vein Grafts in Patients Undergoing Coronary Artery Bypass Graft Procedures
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 E2F Duplex Decoy as compared to placebo on the incidence of patients experiencing vein graft failure after coronary artery bypass surgery
Detailed Description:
Coronary vascular disease manifested by narrowing of the coronary arteries is one of the more common manifestations of atherosclerotic vascular disease The clinical manifestations of coronary artery disease include death angina pectoris myocardial infarction congestive heart failure and arrhythmia Restoration of circulation to the heart may be undertaken using a variety of techniques including angioplasty stenting and bypass grafting
Approximately 359000 patients underwent coronary bypass procedures in the US in 1999 Long term studies have observed an incidence of vein graft occlusion at 19 at 1 year 25 at 5 years and 50 by 15 years after operation for an overall rate of 25 per year after the first year of observation The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia myocardial infarction and death
CGT003 is a novel therapeutic that is under investigation as a treatment to prevent vein graft failure It acts by inhibiting the transcription factor E2F which is activated in response to injury such as that which occurs when thin-walled vein grafts are exposed to the pressures of the arterial circulation Blockade of E2F inhibits smooth muscle cell proliferation and redirects the vein graft remodeling that occurs within the first several days after implantation towards medial hypertrophy and strengthening of the medial layer and blunts formation of neointima Inhibition of neotinimal formation coupled with expansion of the media should result in a decreased risk of the accelerated atherosclerosis and consequent vein graft failure over several years
Approximately 359000 patients underwent coronary bypass procedures in the US in 1999 Long term studies have observed an incidence of vein graft occlusion at 19 at 1 year 25 at 5 years and 50 by 15 years after operation for an overall rate of 25 per year after the first year of observation The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia myocardial infarction and death
CGT003 is a novel therapeutic that is under investigation as a treatment to prevent vein graft failure It acts by inhibiting the transcription factor E2F which is activated in response to injury such as that which occurs when thin-walled vein grafts are exposed to the pressures of the arterial circulation Blockade of E2F inhibits smooth muscle cell proliferation and redirects the vein graft remodeling that occurs within the first several days after implantation towards medial hypertrophy and strengthening of the medial layer and blunts formation of neointima Inhibition of neotinimal formation coupled with expansion of the media should result in a decreased risk of the accelerated atherosclerosis and consequent vein graft failure over several years
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