Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

May 4, 2006 updated by: Anesiva, Inc.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

3000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Todd Lorenz, M.D., Anesiva, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

February 1, 2005

Study Registration Dates

First Submitted

July 22, 2002

First Submitted That Met QC Criteria

July 23, 2002

First Posted (Estimate)

July 24, 2002

Study Record Updates

Last Update Posted (Estimate)

May 5, 2006

Last Update Submitted That Met QC Criteria

May 4, 2006

Last Verified

July 1, 2005

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on CGT003 (E2F Duplex Decoy)

3
Subscribe