Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

This study has been completed.
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00042081
First received: July 22, 2002
Last updated: May 4, 2006
Last verified: July 2005
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Anesiva, Inc.:

Estimated Enrollment: 3000
Study Start Date: July 2002
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PATIENTS MUST:

  • Have coronary artery disease and be scheduled to undergo a coronary artery bypass (CABG) procedure that is to include at least two segments of autogenous vein (sequential grafts do not count as two separate grafts).
  • Be between 18 and 80 years old.
  • Have a documented negative serum pregnancy test for all women of childbearing potential.
  • Be using an acceptable method of birth control if of reproductive potential.
  • Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form.
  • (If one of the first 2400 patients enrolled) have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form for the Angiography population.
  • Note: Patients who are to receive an arterial bypass to the left anterior descending artery in addition to the two vein grafts required by the protocol ARE eligible for this study.
  • Note: Patients ARE eligible for enrollment regardless of whether the planned procedure is to be on or off cardiopulmonary bypass pump.
  • Note: Patients who do not wish to undergo elective Angiography at one year SHOULD NOT be enrolled in the first 2400 patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042081

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center - Montclair
Birmingham, Alabama, United States, 35213
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States, 35213
Medical Center East
Birmingham, Alabama, United States, 35235
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States, 35235
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
Cardio-Thoracic Surgeons, P.C.
Birmingham, Alabama, United States, 35209
United States, California
Seton Medical Center
Daly City, California, United States, 94015
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Desert Regional Medical Center
Palm Springs, California, United States, 92262
St. Joseph's Medical Center
Stockton, California, United States, 95204
United States, Connecticut
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Florida Cardiovascular Research
Atlantis, Florida, United States, 33462
JFK Medical Center
Atlantis, Florida, United States, 33462
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
Orlando Regional Med Center
Orlando, Florida, United States, 32806
Orlando Heart Center
Orlando, Florida, United States, 32806
Orlando Heart Center/Sand Lake
Orlando, Florida, United States, 32819
Orlando Cardiovascular Center, LLLP
Orlando, Florida, United States, 32806
Florida Hospital
Orlando, Florida, United States, 32803
Cardiovascular Surgeons, P.A.
Orlando, Florida, United States, 32801
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239
Clinical Research Center
Sarasota, Florida, United States, 34239
United States, Georgia
Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Memorial Hospital
Belleville, Illinois, United States, 62226
St. Elizabeth's Hospital
Belleville, Illinois, United States, 62220
Rush Professional Building
Chicago, Illinois, United States, 60612
Northwestern Medical Facility Foundation
Chicago, Illinois, United States, 60611
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Resurrection Medical Center
Chicago, Illinois, United States, 60631
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
St. Francis Hospital of Evanston
Evanston, Illinois, United States, 60202
Evanston Northwestern Healthcare, Highland Park Hospital
Evanston, Illinois, United States, 60201
Loyola University Chicago Medical Center
Maywood, Illinois, United States, 60153
Edward Hospital & Health Services
Naperville, Illinois, United States, 60540
Advocate Christ Hospital and Medical Center
Oak Lawn, Illinois, United States, 60453
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery
Springfield, Illinois, United States, 62702
Memorial Medical Center
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery
Springfield, Illinois, United States, 62702
St. John's Hospital
Springfield, Illinois, United States, 62702
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
St. Vincent Hospital and Health Care Service
Indianapolis, Indiana, United States, 46260
The Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Iowa
Genesis Medical Center
Davenport, Iowa, United States, 52803
Genesis Heart Institute
Davenport, Iowa, United States, 52803
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Georgetown Professional Plaza
Overland Park, Kansas, United States, 66204
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Jewish Hospital Health Care Services
Louisville, Kentucky, United States, 40202
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Cardiac Surgery Associates
Baltimore, Maryland, United States, 21215
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
Cardiac Surgery Associates
Towson, Maryland, United States, 21204
Midatlantic Cardiovascular Associates, P.A.
Towson, Maryland, United States, 21204
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
McLaren Regional Medical Center
Flint, Michigan, United States, 48532
Spectrum Health Hospitals
Grand Rapids, Michigan, United States, 49503
Thoracic & Cardiovascular Institute
Lansing, Michigan, United States, 48910
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Petoskey Cardiology
Petoskey, Michigan, United States, 49770
Great Lakes Cardiothoracic and Vascular Surgery
Petoskey, Michigan, United States, 49770
Cardiology Consultants, PC
Petoskey, Michigan, United States, 49770
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48601
Convenant Medical Center
Saginaw, Michigan, United States, 48602
United States, Minnesota
St. Mary's/Duluth Clinic Health System
Duluth, Minnesota, United States, 55805
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Park Nicollet Institute
Minneapolis, Minnesota, United States, 55416
Park Nicollet Heart Center
St. Louis Park, Minnesota, United States, 55426
Methodist Hospital
St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
Forrest General Hospital
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
St. John's Regional Medical Center
Joplin, Missouri, United States, 64804
930 Carondelet Drive
Kansas City, Missouri, United States, 64114
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
United States, Nebraska
Nebraska Heart Institute
Omaha, Nebraska, United States, 68131
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68131
Nebraska Heart Institute
Papillion, Nebraska, United States, 68046
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Umdnj-Rwjms
New Brunswick, New Jersey, United States, 08903
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
New York Presbyterian Medical Center, Milstein Hospital Building
New York, New York, United States, 10032
Lenox Hill Hospital
New York, New York, United States, 10021
Westchester Medical Center
Valhalla, New York, United States, 10595
United States, North Carolina
Ambulatory Care Center
Chapel Hill, North Carolina, United States, 27514
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27154
Duke University Medical Center
Durham, North Carolina, United States, 27710
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27834
Brody School of Medicine, East Carolina University
Greenville, North Carolina, United States, 27858
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Walley, Morgan & Duncan, M.D., P.A.
Winston Salem, North Carolina, United States, 27103
Forysyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
MeritCare Clinic at MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Aultman Health Foundation
Canton, Ohio, United States, 44710
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Cardiovascular & Thoracic Surgeons
Cincinnati, Ohio, United States, 45220
Cardiovascular & Thoracic Surgeons, Inc.
Cincinnati, Ohio, United States, 45242
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Kettering Medical Center Network, Kettering Hospital
Kettering, Ohio, United States, 45429
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Presbyterian Hospital, University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center, Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Guthrie Clinic
Sayre, Pennsylvania, United States, 18840
The Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Carolina
Upstate Cardiothoracic Surgery, Greenville Hospital System
Greenville, South Carolina, United States, 29605
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Saint Francis Hospital
Memphis, Tennessee, United States, 38119
United States, Texas
Heart Hospital of Austin
Austin, Texas, United States, 78756
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
St. Paul University Hospital
Dallas, Texas, United States, 75235
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
Denton Regional Medical Center
Denton, Texas, United States, 76210
Medical Center Plano
Plano, Texas, United States, 75075
Northeast Methodist Hospital
San Antonio, Texas, United States, 78233
Southwest Texas Methodist Hospital
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Lynchburg General Hospital
Lynchburg, Virginia, United States, 24501
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Mid-Atlantic Cardiothoracic Surgeons, Ltd.
Norfolk, Virginia, United States, 23510
United States, Washington
St. Joseph Hospital
Bellingham, Washington, United States, 98225
Deaconess Medical Center
Spokane, Washington, United States, 99204
Northwest Heart and Lung Surgical Associates
Spokane, Washington, United States, 99204
United States, West Virginia
CAMC Health Education and Research Institute, Clinical Trials Center
Charleston, West Virginia, United States, 25304
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Appleton Heart Institute at Appleton Medical Center
Appleton, Wisconsin, United States, 54911
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188
Community Health Care/Wausau Hospital
Wausau, Wisconsin, United States, 54401
Wausau Heart and Lung Surgeons
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Anesiva, Inc.
Investigators
Study Director: Todd Lorenz, M.D. Anesiva, Inc.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00042081     History of Changes
Other Study ID Numbers: CGT003-04
Study First Received: July 22, 2002
Last Updated: May 4, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Anesiva, Inc.:
CABG
coronary artery bypass surgery
coronary artery disease
coronary arteriosclerosis
coronary stenosis
coronary occlusion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014