Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00042081
- Lead Sponsor
- Anesiva, Inc.
- 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 359,000 patients underwent coronary bypass procedures in the U.S. 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 2.5% 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (150)
Brookwood Medical Center
🇺🇸Birmingham, Alabama, United States
Cardio-Thoracic Surgeons, P.C.
🇺🇸Birmingham, Alabama, United States
Baptist Medical Center - Montclair
🇺🇸Birmingham, Alabama, United States
Medical Center East
🇺🇸Birmingham, Alabama, United States
Seton Medical Center
🇺🇸Daly City, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
St. Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (140 remaining)Brookwood Medical Center🇺🇸Birmingham, Alabama, United States