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AzTrials

Coronary Artery DiseasePhase 3NCT00042081

Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures

A Phase 3 study testing CGT003 (E2F Duplex Decoy) in people with Coronary Artery Disease, run by Anesiva, Inc. at 154 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
CGT003 (E2F Duplex Decoy)
How many people
3,000 participants
Where
154 sitesUnited States
Study dates
Jul 2002to Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

154 sites in 1 country.

154 sites in 1 country

United States154 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Appleton Heart Institute at Appleton Medical Center

    Appleton, Wisconsin, 54911

  • Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Florida Cardiovascular Research

    Atlantis, Florida, 33462

  • JFK Medical Center

    Atlantis, Florida, 33462

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Cardiac Surgery Associates

    Baltimore, Maryland, 21215

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • St. Elizabeth's Hospital

    Belleville, Illinois, 62220

  • Memorial Hospital

    Belleville, Illinois, 62226

  • St. Joseph Hospital

    Bellingham, Washington, 98225

  • St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • Brookwood Medical Center

    Birmingham, Alabama, 35209

  • Cardio-Thoracic Surgeons, P.C.

    Birmingham, Alabama, 35209

  • Baptist Medical Center - Montclair

    Birmingham, Alabama, 35213

  • Cardio-Thoracic Surgeons, P.C.

    Birmingham, Alabama, 35213

  • Cardio-Thoracic Surgeons, P.C.

    Birmingham, Alabama, 35235

  • Medical Center East

    Birmingham, Alabama, 35235

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27154

  • Ambulatory Care Center

    Chapel Hill, North Carolina, 27514

  • CAMC Health Education and Research Institute, Clinical Trials Center

    Charleston, West Virginia, 25304

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • Northwestern Medical Facility Foundation

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush Presbyterian St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Rush Professional Building

    Chicago, Illinois, 60612

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • Cardiovascular & Thoracic Surgeons

    Cincinnati, Ohio, 45220

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Cardiovascular & Thoracic Surgeons, Inc.

    Cincinnati, Ohio, 45242

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Presbyterian Hospital of Dallas

    Dallas, Texas, 75231

  • St. Paul University Hospital

    Dallas, Texas, 75235

  • Seton Medical Center

    Daly City, California, 94015

  • Genesis Heart Institute

    Davenport, Iowa, 52803

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Denton Regional Medical Center

    Denton, Texas, 76210

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • St. Mary's/Duluth Clinic Health System

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Evanston Northwestern Healthcare, Highland Park Hospital

    Evanston, Illinois, 60201

  • Evanston Northwestern Healthcare

    Evanston, Illinois, 60201

  • St. Francis Hospital of Evanston

    Evanston, Illinois, 60202

  • MeritCare Clinic at MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • McLaren Regional Medical Center

    Flint, Michigan, 48532

  • Gaston Memorial Hospital

    Gastonia, North Carolina, 28054

  • Spectrum Health Hospitals

    Grand Rapids, Michigan, 49503

  • Pitt County Memorial Hospital

    Greenville, North Carolina, 27834

  • Brody School of Medicine, East Carolina University

    Greenville, North Carolina, 27858

  • Greenville Hospital System

    Greenville, South Carolina, 29605

  • Upstate Cardiothoracic Surgery, Greenville Hospital System

    Greenville, South Carolina, 29605

  • Forrest General Hospital

    Hattiesburg, Mississippi, 39401

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • St. Vincent Hospital and Health Care Service

    Indianapolis, Indiana, 46260

  • The Heart Center of Indiana

    Indianapolis, Indiana, 46290

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • St. John's Regional Medical Center

    Joplin, Missouri, 64804

  • 930 Carondelet Drive

    Kansas City, Missouri, 64114

  • Kettering Medical Center Network, Kettering Hospital

    Kettering, Ohio, 45429

  • Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Thoracic & Cardiovascular Healthcare Foundation

    Lansing, Michigan, 48910

  • Thoracic & Cardiovascular Institute

    Lansing, Michigan, 48910

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jewish Hospital Health Care Services

    Louisville, Kentucky, 40202

  • Lynchburg General Hospital

    Lynchburg, Virginia, 24501

  • Loyola University Chicago Medical Center

    Maywood, Illinois, 60153

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • Saint Francis Hospital

    Memphis, Tennessee, 38119

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Park Nicollet Institute

    Minneapolis, Minnesota, 55416

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Edward Hospital & Health Services

    Naperville, Illinois, 60540

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Umdnj-Rwjms

    New Brunswick, New Jersey, 08903

  • Lenox Hill Hospital

    New York, New York, 10021

  • New York Presbyterian Medical Center, Milstein Hospital Building

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Mid-Atlantic Cardiothoracic Surgeons, Ltd.

    Norfolk, Virginia, 23510

  • Advocate Christ Hospital and Medical Center

    Oak Lawn, Illinois, 60453

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Nebraska Heart Institute

    Omaha, Nebraska, 68131

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68131

  • Cardiovascular Surgeons, P.A.

    Orlando, Florida, 32801

  • Florida Hospital

    Orlando, Florida, 32803

  • Orlando Cardiovascular Center, LLLP

    Orlando, Florida, 32806

  • Orlando Heart Center

    Orlando, Florida, 32806

  • Orlando Regional Med Center

    Orlando, Florida, 32806

  • Orlando Heart Center/Sand Lake

    Orlando, Florida, 32819

  • Georgetown Professional Plaza

    Overland Park, Kansas, 66204

  • Desert Regional Medical Center

    Palm Springs, California, 92262

  • Nebraska Heart Institute

    Papillion, Nebraska, 68046

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • Cardiology Consultants, PC

    Petoskey, Michigan, 49770

  • Great Lakes Cardiothoracic and Vascular Surgery

    Petoskey, Michigan, 49770

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Petoskey Cardiology

    Petoskey, Michigan, 49770

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Presbyterian Hospital, University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center, Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Medical Center Plano

    Plano, Texas, 75075

  • Maine Medical Center

    Portland, Maine, 04102

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Michigan Cardiovascular Institute

    Saginaw, Michigan, 48601

  • Convenant Medical Center

    Saginaw, Michigan, 48602

  • Methodist Hospital

    Saint Louis Park, Minnesota, 55426

  • Park Nicollet Heart Center

    Saint Louis Park, Minnesota, 55426

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • Southwest Texas Methodist Hospital

    San Antonio, Texas, 78229

  • Northeast Methodist Hospital

    San Antonio, Texas, 78233

  • Clinical Research Center

    Sarasota, Florida, 34239

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

  • Guthrie Clinic

    Sayre, Pennsylvania, 18840

  • Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Northwest Heart and Lung Surgical Associates

    Spokane, Washington, 99204

  • Memorial Medical Center

    Springfield, Illinois, 62702

  • Southern Illinois University School of Medicine, Dep. of Surgery, Div. of Cardiothoracic Surgery

    Springfield, Illinois, 62702

  • Southern Illinois University School of Medicine, Department of Surgery, Division of Cardiothoracic Surgery

    Springfield, Illinois, 62702

  • St. John's Hospital

    Springfield, Illinois, 62702

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • St. Joseph's Medical Center

    Stockton, California, 95204

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Cardiac Surgery Associates

    Towson, Maryland, 21204

  • Midatlantic Cardiovascular Associates, P.A.

    Towson, Maryland, 21204

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Community Health Care/Wausau Hospital

    Wausau, Wisconsin, 54401

  • Wausau Heart and Lung Surgeons

    Wausau, Wisconsin, 54401

  • The Chester County Hospital

    West Chester, Pennsylvania, 19380

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Forysyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Walley, Morgan & Duncan, M.D., P.A.

    Winston-Salem, North Carolina, 27103

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this 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

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.

Read the 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.

Being tested
CGT003 (E2F Duplex Decoy)
Keywords
CABG, coronary artery bypass surgery, coronary artery disease, coronary arteriosclerosis, coronary stenosis, coronary occlusion
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, Coronary Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGT003 (E2F Duplex Decoy)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2002 (estimated)
  2. Study startJul 2002
  3. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
3,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042081
Sponsor's protocol ID
CGT003-04
Status last verified
Jul 2005
First submitted
22 Jul 2002
Last updated
5 May 2006
Results posted
No

Publications

  • Alexander JH, Hafley G, Harrington RA, Peterson ED, Ferguson TB Jr, Lorenz TJ, Goyal A, Gibson M, Mack MJ, Gennevois D, Califf RM, Kouchoukos NT; PREVENT IV Investigators. Efficacy and safety of edifoligide, an E2F transcription factor decoy, for prevention of vein graft failure following coronary artery bypass graft surgery: PREVENT IV: a randomized controlled trial. JAMA. 2005 Nov 16;294(19):2446-54. doi: 10.1001/jama.294.19.2446.

    PubMed 16287955

  • Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.

    PubMed 26647082

  • Hess CN, Lopes RD, Gibson CM, Hager R, Wojdyla DM, Englum BR, Mack MJ, Califf RM, Kouchoukos NT, Peterson ED, Alexander JH. Saphenous vein graft failure after coronary artery bypass surgery: insights from PREVENT IV. Circulation. 2014 Oct 21;130(17):1445-51. doi: 10.1161/CIRCULATIONAHA.113.008193. Epub 2014 Sep 26.

    PubMed 25261549

  • Harskamp RE, Alexander JH, Schulte PJ, Brophy CM, Mack MJ, Peterson ED, Williams JB, Gibson CM, Califf RM, Kouchoukos NT, Harrington RA, Ferguson TB Jr, Lopes RD. Vein graft preservation solutions, patency, and outcomes after coronary artery bypass graft surgery: follow-up from the PREVENT IV randomized clinical trial. JAMA Surg. 2014 Aug;149(8):798-805. doi: 10.1001/jamasurg.2014.87.

    PubMed 25073921

  • Lopes RD, Williams JB, Mehta RH, Reyes EM, Hafley GE, Allen KB, Mack MJ, Peterson ED, Harrington RA, Gibson CM, Califf RM, Kouchoukos NT, Ferguson TB, Lorenz TJ, Alexander JH. Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results. Am Heart J. 2012 Sep;164(3):379-386.e1. doi: 10.1016/j.ahj.2012.05.019.

    PubMed 22980305

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CGT003 (E2F Duplex Decoy) in people with Coronary Artery Disease, run by Anesiva, Inc. at 154 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00042081, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2006.

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