Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00451256
Status:
TERMINATED
Last Update Posted:
2009-07-08
First Post:
2007-03-21
Brief Title:
Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery CABG
Sponsor:
Sarepta Therapeutics Inc
Organization:
Sarepta Therapeutics Inc
Study Overview
Official Title:
Clinical Study to Assess the Safety and Efficacy of ex-Vivo Vein Graft Exposure to AVI-5126 in Coronary Artery By-Pass Grafting to Reduce Clinical Graft Failure
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol-defined outcome in terms of efficacy would not be achieved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For some people who have heart by-pass surgery the vein that is used to by-pass a blockage will after some time become narrowed and possibly blocked AVI-5126 blocks a gene that is believed to be responsible for the events in the blood vessel that cause this narrowing Therefore exposing the vein to AVI-5126 before it is attached to the coronary artery may result in less problems with these vein grafts later on This study will determine if this procedure is both safe and effective
Detailed Description:
Coronary artery bypass CABG is a common procedure employed for life-threatening cardiovascular disease While bypass surgery is effective in restoring blood flow in the short-term 30 to 50 percent of venous bypass grafts eventually become blocked or fail Within the first year after a CABG procedure it is estimated that between 15 and 30 of saphenous vein grafts fail ie 75 reduction in flow within the graft due to intimal hyperplasia at the anastomosis sites There is currently no approved treatment to prevent venous graft failure These patients may frequently undergo a second bypass surgery if the extent of graft failures is sufficiently severe to lead to uncontrolled angina pectoris It is clear that a second CABG procedure in a patient represents a higher operative mortality rate than the first procedure Venous graft failure in CABG is a major unmet medical-surgical problem
AVI has previously focused some of its Neugene products in the area of preventing cardiovascular stenosis This application of antisense targeted to to inhibit the c-myc gene has previously been demonstrated to prevent sequelae of intimal hyperplasia following endovascular injury The purpose of this study is to evaluate whether immersion of the excised saphenous vein in a novel anti-c-myc antisense drug AVI-5126 solution will prevent subsequent graft failure at 1 year compared to physiological saline placebo prior to graft anastomosis
AVI has previously focused some of its Neugene products in the area of preventing cardiovascular stenosis This application of antisense targeted to to inhibit the c-myc gene has previously been demonstrated to prevent sequelae of intimal hyperplasia following endovascular injury The purpose of this study is to evaluate whether immersion of the excised saphenous vein in a novel anti-c-myc antisense drug AVI-5126 solution will prevent subsequent graft failure at 1 year compared to physiological saline placebo prior to graft anastomosis
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