Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Anesiva, Inc. |
---|---|
Information provided by: | Anesiva, Inc. |
ClinicalTrials.gov Identifier: | NCT00042081 |
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.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Drug: CGT003 (E2F Duplex Decoy) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 3000 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | February 2005 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PATIENTS MUST:
Study Director: | Todd Lorenz, M.D. | Anesiva, Inc. |
Study ID Numbers: | CGT003-04 |
Study First Received: | July 22, 2002 |
Last Updated: | May 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00042081 |
Health Authority: | United States: Food and Drug Administration |
CABG coronary artery bypass surgery coronary artery disease |
coronary arteriosclerosis coronary stenosis coronary occlusion |
Arterial Occlusive Diseases Coronary Occlusion Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Constriction, Pathologic Ischemia Arteriosclerosis Coronary Stenosis Coronary Artery Disease |
Cardiovascular Diseases |