ARISE - Aggressive Reduction of Inflammation Stops Events

"Reduction of Vascular Inflammation and Coronary Atherosclerosis With AGI-1067, a V-Protectant, Reduces Cardiovascular Events in Patients With Coronary Artery Disease"

To assess the safety and efficacy of AGI-1067, as compared to placebo, in the treatment of vascular inflammation and atherosclerosis by assessing the reduction in cardiovascular events.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Coronary Artery Disease; Atherosclerosis; Unstable Angina
• Intervention / Treatment: Drug: AGI-1067

Detailed Description

This study will be a Phase III multi-center, double-blind, parallel group, placebo-controlled trial involving approximately 260 study sites in the United States, Canada, South Africa and the United Kingdom. It is expected that approximately 6,600 subjects will be screened in order to randomize approximately 6,000 subjects globally (3,000 in each arm of the study). Male or female subjects with coronary artery disease are eligible to participate if they meet all required inclusion and exclusion criteria. Recruitment will be delayed for one month in subjects who have had a PCI. Subjects who have a PCI planned at the time of screening or randomization, will not be randomized until one month after this planned PCI has been conducted. All subjects who successfully complete the screening phase and meet all required inclusion and exclusion criteria will be entered into the single-blind, placebo Run-In phase of the study to establish compliance. The placebo Run-In medication will be identical to the blinded study drug used in the randomized portion of the study. After the completion of the two-week Run-In, if compliance has been adequate, study subjects will be randomized to receive AGI-1067 300 mg (two 150 mg tablets daily with a meal) or placebo (approximately equal numbers of subjects per treatment group) for a minimum of 12 months. It is anticipated that subject accrual will occur over a period of approximately 24 months and that all subjects will be followed until at least 990 subjects have experienced a primary event. Subjects will remain on drug therapy from randomization until the end of the study. It is estimated that the first subject recruited will be exposed to blinded therapy for 30 to 36 months, and the last subject will be exposed for a minimum of 6 to 12 months. For the purposes of this study one month will be equal to 28 days. The subject will be asked to return to the clinic at 1 month, 3 months, and every 3 months thereafter during the treatment phase. All clinical laboratory procedures and electrocardiographic interpretations will be performed by central laboratories. Over the study period, subjects will be followed for the occurrence of major adverse cardiovascular events. These potential endpoints will be adjudicated by an independent endpoint committee. This committee will consist of cardiologists and other physician reviewers who will be blinded to the treatment. For the purposes of safety, the trial will be monitored by an independent Data Safety Monitoring Board. This Board will consist of Cardiologists, and at least one Statistician experienced in the conduct of clinical trials. The Board will meet approximately every 6 months to review subject safety data.

• Study Type: Interventional
• Enrollment: 6000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Foothills Hospital Cardiology Div
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
  • British Columbia
    • New Westminster, British Columbia, Canada
      • West Coast Cardiology Research
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Health Sciences Centre
    • Winnipeg, Manitoba, Canada
      • St Boniface General Hospital
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada
      • Health Sciences Centre Div of Cardiology
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth Health Sciences Centre
  • Ontario
    • Burlington, Ontario, Canada
      • Halton Heart Institute
    • Hamilton, Ontario, Canada
      • St Joseph Health Care Hamilton
    • Kingston, Ontario, Canada
      • Kingston Heart Clinic
    • London, Ontario, Canada
      • London Health Sci Cntr Site
    • London, Ontario, Canada
      • Mount St. Joseph's
    • Newmarket, Ontario, Canada
      • Newmarket Cardiology Research
    • Oshawa, Ontario, Canada
      • Heart Care Research
    • Ottawa, Ontario, Canada
      • Ottawa Cardiovascular Center
    • Ottawa, Ontario, Canada
      • Vexler Health Services
    • Sudbury, Ontario, Canada
      • The Office of Dr. Syan Gurcharan
    • Thunder Bay, Ontario, Canada
      • Cliks Medical Research
    • Thunder Bay, Ontario, Canada
      • Thunder Bay Regional Health Science Ctr
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook and Women's College
    • Toronto, Ontario, Canada
      • University Health Network - Toronto Western Hosp
  • Quebec
    • Chicoutimi, Quebec, Canada
      • CMGC-GRID Complexe Hosp
    • Gatineau, Quebec, Canada
      • Q & T Research Outaouais
    • Granby, Quebec, Canada
      • Recherches Cliniques Theradev
    • Greenfield Park, Quebec, Canada
      • The Office of Dr. Jean-Robert Timothee
    • Greenfield Park, Quebec, Canada
      • Viacar Recherche Clinique
    • Joliette, Quebec, Canada
      • Hosp Regional de Lanaudiere
    • Laval, Quebec, Canada
      • Cite de La Sante de Laval
    • Levis, Quebec, Canada
      • Clinique de Cardiologie de Levis
    • Longueuil, Quebec, Canada
      • Medicayeb, Inc.
    • Longueuil, Quebec, Canada
      • Viacar Recherche Clinique Inc.
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
    • Montreal, Quebec, Canada
      • Hopital Du Sacre Coeur de Montreal
    • Montreal, Quebec, Canada
      • Chum Hopital Notre Dame
    • Montreal, Quebec, Canada
      • CUSM Montreal General Hosp
    • Montreal, Quebec, Canada
      • Maisonneuve Rosemont Hosp
    • Montreal, Quebec, Canada
      • McGill Univ Health Cntr
    • Montreal, Quebec, Canada
      • Medi-Recherche Inc.
    • Quebec City, Quebec, Canada
      • Recherches Clinicar
    • Saint Hyacinthe, Quebec, Canada
      • Reseau Sante Richelieu Yamaska
    • Saint Jerome, Quebec, Canada
      • Zoom International
    • Saint-Lambert, Quebec, Canada
      • Neufort Inc.
    • Sherbrooke, Quebec, Canada
      • London Clinical Research
    • St. George, Quebec, Canada
      • Cntr Hospital Beauce Etchemin
    • St.-Jean sur Richelieu, Quebec, Canada
      • Hopital du Haut-Richelieu
    • Ste-Foy, Quebec, Canada
      • Laval Hospital Pavillion 2U
    • Terrebonne, Quebec, Canada
      • Cntr Hospitalier Pierre Le Gardeur
    • Val d'Or, Quebec, Canada
      • Centre Hospitalier de Val d'Or
    • Victoriaville, Quebec, Canada
      • Societe des internistes Bois Fran
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Pasqua Hosp Coronary Care Unit
    • Saskatoon, Saskatchewan, Canada
      • Royal University Hospital
    • Saskatoon, Saskatchewan, Canada
      • Saskatoon Medical Specialists
• South Africa
  • BLM
    • Bloemfontein, BLM, South Africa
      • Dr. Johann Viljoen
    • Bloemfontein, BLM, South Africa
      • Fichmed 5, Rosepark Hospital
    • Bloemfontein, BLM, South Africa
      • Universitas Hospital
  • CT
    • Panorama, CT, South Africa
      • 228 Panorama Medi Clinic
    • Panorama, CT, South Africa
      • Panorama Medical Clinic
    • Parow, CT, South Africa
      • Tygerberg hospital
    • Pinelands, CT, South Africa
      • Vincent Pallotti Hospital
    • Somerset West, CT, South Africa
      • Vergelegen Medical Clinic
  • DBN
    • Chatsworth, DBN, South Africa
      • Chatsmed Garden Hospital
    • Chatsworth, DBN, South Africa
      • Chatsmed Hospital
    • Durban, DBN, South Africa
      • 403 Maxwell Centre
  • JHB
    • Fordsburg, JHB, South Africa
      • United House
    • Halfway House, JHB, South Africa
      • The Boulders Shopping Center
    • Mulbarton, JHB, South Africa
      • Mulbarton Medical Center
    • Olivedale, JHB, South Africa
      • Olivedale Clinic
    • Sunninghill,, JHB, South Africa
      • Sunninghill Hospital
  • PTA
    • Arcadia, PTA, South Africa
      • Pretoria Heart Hospital
    • Lyttelton Centurion, PTA, South Africa
      • Unitas Hospital
    • The Willows, PTA, South Africa
      • Wilgers Medical Consortium
• United Kingdom
  • Aberdeen, United Kingdom
    • Grampian University Hospitals NHS Trust
  • Birmingham, United Kingdom
    • Sandwell & West Birmingham City Hospital NHS Trust
  • Cambridge, United Kingdom
    • Papworth Hospital NHS Trust
  • Edinburgh, United Kingdom
    • The Lothian University Hospitals NHS Trust
  • Glasglow, United Kingdom
    • North Glasglow University Hospitals NHS Trust
  • Glasglow, United Kingdom
    • South Glasglow University Hospital NHS Trust
  • Glasglow, United Kingdom
    • Western Infirmary Glaglow
  • Leeds, United Kingdom
    • The Leeds Teaching Hospitals Nhs Trust
  • Leicester, United Kingdom
    • University Hospitals Of Leicester Nhs Trust
  • Liverpool, United Kingdom
    • Liverpool NHS Trust
  • Manchester, United Kingdom
    • South Manchester University Hospitals NHS Trust
  • Paisley, United Kingdom
    • Argyll & Clyde NHS Trust
  • Sheffield, United Kingdom
    • Sheffield Teaching Hospitals NHS Trust
  • Stirling, United Kingdom
    • Forth Valley Acute Hospitals NHS Trust
  • Stok-on-Trent, United Kingdom
    • University Hospitals of North Staffordshire NHS Trust
  • Wakefield, United Kingdom
    • Mid Yorkshire Hospitals
  • England
    • London, England, United Kingdom
      • King's College Hospital NHS Trust
  • Essex
    • Romford, Essex, United Kingdom
      • Barking, Havering & Redbridge Hospital NHS Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Cardiovascular Associates
    • Birmingham, Alabama, United States
      • Univ of Alabama at Birmingham
    • Huntsville, Alabama, United States
      • The Heart Center/Oracle Research
  • Arizona
    • Mesa, Arizona, United States
      • Tri-City Cardiology Consultants
    • Mesa, Arizona, United States
      • Tri City Cardiology Consultants
    • Phoenix, Arizona, United States
      • Hope Research Institute
    • Phoenix, Arizona, United States
      • Lovelace Scientific Resources
    • Scottsdale, Arizona, United States
      • Sonoran Health Specialists
  • California
    • Carmichael, California, United States
      • Capitol Interventional Cardiology
    • Escondido, California, United States
      • Escondido Cardiology
    • Merced, California, United States
      • Merced Heart Associates
    • Orange, California, United States
      • Orange County Research Cntr
    • Redondo Beach, California, United States
      • ARI Clinical Trials
    • Santa Rosa, California, United States
      • Radiant Research
  • Colorado
    • Colorado Springs, Colorado, United States
      • Pikes Peak Cardiology
    • Denver, Colorado, United States
      • Aurora Denver Cardiololgy Associates
    • Fort Collins, Colorado, United States
      • Heart and Vascular Clinic N CO
  • Connecticut
    • Bridgeport, Connecticut, United States
      • Connecticut Clinical Research
    • Trumbull, Connecticut, United States
      • Cardiac Specialists, PC
  • Delaware
    • Newark, Delaware, United States
      • Christiana Care Health Svcs
  • Florida
    • Clearwater, Florida, United States
      • Clinical Research of West Florida, Inc.
    • Fort Myers, Florida, United States
      • SW Florida Heart Group
    • Gainesville, Florida, United States
      • Univ of Florida, Cardiology
    • Jacksonville, Florida, United States
      • Diagnostic Cardiology
    • Jacksonville, Florida, United States
      • Jacksonville Cntr Clin Research
    • Jacksonville Beach, Florida, United States
      • Jacksonville Heart Center
    • Lakeland, Florida, United States
      • Watson Clinic LLP
    • Miami, Florida, United States
      • Cardiovascular Research Center of South Florida
    • Orlando, Florida, United States
      • Orlando Heart Cntr
    • Sarasota, Florida, United States
      • Cardiovascular Cntr of Sarasota
    • Tamarac, Florida, United States
      • The Broward Heart Group
    • Tampa, Florida, United States
      • Clinical Research of West Florida, Inc.
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University Hospital
    • Atlanta, Georgia, United States
      • Crawford Long Hospital
    • Atlanta, Georgia, United States
      • Fuqua Hrt Cntr Piedmont Hosp
    • Rome, Georgia, United States
      • Harbin Clinic
  • Idaho
    • Boise, Idaho, United States
      • Idaho Cardiology Associates
  • Illinois
    • Blue Island, Illinois, United States
      • Heart Care Research Foundation
    • Chicago, Illinois, United States
      • Peryam and Kroll Healthcare
    • Peoria, Illinois, United States
      • Heartcare Midwest Heart Inst
  • Indiana
    • Evansville, Indiana, United States
      • The Heart Group
    • Evansville, Indiana, United States
      • Welborn Clinic Research Center
    • Fort Wayne, Indiana, United States
      • Parkview Hospital
    • Indianapolis, Indiana, United States
      • Care Group St. Vincent Hosp of IN
    • Jeffersonville, Indiana, United States
      • Research Inst of Middle America
  • Iowa
    • Des Moines, Iowa, United States
      • Iowa Heart Center
    • Iowa City, Iowa, United States
      • Univ of IA College of Medicine
  • Kansas
    • Wichita, Kansas, United States
      • Research Inst of Kansas Inc
  • Kentucky
    • Louisville, Kentucky, United States
      • Cardiovascular Associates
  • Louisiana
    • Chalmette, Louisiana, United States
      • LOUISIANA HEART Center
    • Lake Charles, Louisiana, United States
      • The Office of Dr. Richard Gilmore
    • Marrero, Louisiana, United States
      • Heart Clinic of Louisiana
    • Morgan City, Louisiana, United States
      • Cardiovascular Inst of the South
    • New Iberia, Louisiana, United States
      • Cardiovascular Inst of the South
    • New Orleans, Louisiana, United States
      • Louisiana Clinical Trials
    • New Orleans, Louisiana, United States
      • Tulane Univ Medical Center
    • Slidell, Louisiana, United States
      • Medical Research Institute
    • Thibodaux, Louisiana, United States
      • Cardiovascular Inst of South
  • Maine
    • Auburn, Maine, United States
      • Androscoggin Cardiology
  • Maryland
    • Baltimore, Maryland, United States
      • Midatlantic Cardiovascular Associates
    • Baltimore, Maryland, United States
      • Midatlantic Cardiovascular
    • Bel Air, Maryland, United States
      • Midatlantic Cardiovascular
    • Columbia, Maryland, United States
      • Patuxent Medical Group
    • Oxon Hill, Maryland, United States
      • MD Med Research Ong Med Cntr
    • Towson, Maryland, United States
      • Midatlantic Cardiovascular
    • Westminster, Maryland, United States
      • Midatlantic Cardiovascular
  • Massachusetts
    • Abington, Massachusetts, United States
      • Compass Medical Associates
    • Boston, Massachusetts, United States
      • Gary Brockington, MD
    • Burlington, Massachusetts, United States
      • Lahey Clinic Med Cntr
    • Haverhill, Massachusetts, United States
      • Pentucket Med Assoc Inc
    • Natick, Massachusetts, United States
      • Charles River Med Associates
  • Michigan
    • Cadillac, Michigan, United States
      • Professional Clinical Research
    • Kalamazoo, Michigan, United States
      • Borgess Medical Center
    • Livonia, Michigan, United States
      • The Office of Dr. Keith Pierce
    • Royal Oak, Michigan, United States
      • Beaumont Medical Office Bldg
    • Troy, Michigan, United States
      • Michigan Heart Group
  • Minnesota
    • St Paul, Minnesota, United States
      • St Paul Heart Clinic
  • Missouri
    • Kansas City, Missouri, United States
      • N'Touch Research
    • St Louis, Missouri, United States
      • St Louis Univ Div Solutions
    • St Louis, Missouri, United States
      • St Louis Univ Hospital
    • St Louis, Missouri, United States
      • Washington Univ School of Med
  • Nebraska
    • Lincoln, Nebraska, United States
      • Nebraska Heart Institute
    • Omaha, Nebraska, United States
      • Creighton Cardiac Center
    • Papillion, Nebraska, United States
      • Nebraska Heart Institute
  • New Jersey
    • Elmer, New Jersey, United States
      • Cardiovascular Assoc of Delaware Valley
    • Haddon Heights, New Jersey, United States
      • Cardiovascular Associates of the Delaware Valley
  • New York
    • Brooklyn, New York, United States
      • SUNY Downstate Health Science Ctr
    • New York, New York, United States
      • St Vincent's Med Cntr NY
    • Syracuse, New York, United States
      • SUNY Upstate Medical Univ
    • Syracuse, New York, United States
      • Syracuse Preventive Cardiology
    • Williamsville, New York, United States
      • Buffalo Cardiology and Pulmonary Associates
  • North Carolina
    • Charlotte, North Carolina, United States
      • Mid Carolina Cardiology Research Div
  • Ohio
    • Akron, Ohio, United States
      • City Cardiology Associates
    • Cincinnati, Ohio, United States
      • New Horizons Clinical Research
    • Cincinnati, Ohio, United States
      • Lindner Clinical Trial Center
    • Cincinnati, Ohio, United States
      • Sterling Research Group
    • Sandusky, Ohio, United States
      • North Ohio Heart Center
  • Oklahoma
    • Bartlesville, Oklahoma, United States
      • BlueStem Cardiology
    • Oklahoma City, Oklahoma, United States
      • COR Clinical Research, LLC
    • Tulsa, Oklahoma, United States
      • Castlerock Clinical Research Consultants
  • Pennsylvania
    • Allentown, Pennsylvania, United States
      • The Heart Care Group
    • Beaver, Pennsylvania, United States
      • Tri-State Medical Group
    • Danville, Pennsylvania, United States
      • Geisinger Medical Center
    • Harrisburg, Pennsylvania, United States
      • Kandra, Fierer, Kuskin Associates
    • Pittsburgh, Pennsylvania, United States
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States
      • Banksville Medical
  • Rhode Island
    • Woonsocket, Rhode Island, United States
      • Rhode Island Cardiovascular Group
  • South Carolina
    • Charleston, South Carolina, United States
      • Charleston Cardiology
    • Greer, South Carolina, United States
      • Internal Medicine Of Greer
  • Tennessee
    • Clarksville, Tennessee, United States
      • Alpha Clinical Research
    • Knoxville, Tennessee, United States
      • CardioVascular Research Foundation
  • Texas
    • Amarillo, Texas, United States
      • Pharma Tex Research
    • Amarillo, Texas, United States
      • Amarillo Heart Clinical Research Institute
    • Austin, Texas, United States
      • Austin Heart PA
    • Beaumont, Texas, United States
      • Southeast Texas Cardiology Associates II
    • Dallas, Texas, United States
      • Clinical Cardiovascular Research Cntr
    • Houston, Texas, United States
      • The Methodist Hospital
    • Nassau Bay, Texas, United States
      • Research Clinic
    • San Antonio, Texas, United States
      • Sioco Cardiology, PA
  • Utah
    • Salt Lake City, Utah, United States
      • Heart Center
    • Salt Lake City, Utah, United States
      • IHC Health Services
  • Virginia
    • South Boston, Virginia, United States
      • DUCCS Research of S Boston
  • Washington
    • Burien, Washington, United States
      • Daniel Gottlieb MD PS
    • Seattle, Washington, United States
      • U of WA NW Lipid Research Cntr
  • Wisconsin
    • Appleton, Wisconsin, United States
      • Appleton Heart Inst
    • Elkhorn, Wisconsin, United States
      • Wisconsin Center for Clinical Research
    • Milwaukee, Wisconsin, United States
      • Medical College of Wisconsin
    • Wauwatosa, Wisconsin, United States
      • Allegiance Research Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

IRB-approved informed written consent must be provided by all subjects prior to screening and study entry.

A. Inclusion Criteria

1. Informed written consent from the subject prior to Screening
2. Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization

3. Male or female subjects in one of the two following groups:

   1. Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older
   2. Subjects (without diabetes mellitus) 55 years of age or older with one of the following additional risk factors:

   (i) Age 60 or older (ii) Low HDL-C as evidenced by: Male: HDL-C < 40 mg/dL or Female: HDL-C < 50 mg/dL (iii) Previous Myocardial Infarction (in addition to the index event), or diagnosis of Atherosclerosis in a non-coronary vessel (e.g. history of prior stroke, presence of PVD) (iv) Prior history of CHF (Congestive Heart Failure) or ejection fraction < 40%

4. Females must be non-lactating and not of child bearing potential

B. Exclusion Criteria

1. Subjects who are hemodynamically or clinically unstable
2. Subjects who have had a PCI in the last 30 days
3. Subjects who have had coronary artery bypass (CABG) in the last 3 months
4. Subjects on a waiting list for revascularization or revascularization already planned
5. Current symptoms consistent with moderate or severe CHF despite medical therapy
6. Clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy
7. Uncontrolled hypertension (e.g., sitting systolic BP > 180 mm Hg on antihypertensive therapy)
8. Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
9. Subjects taking and requiring continued therapy with drugs known to significantly prolong the QT interval (this will not include drugs associated with minor effect on the QT interval of less than 15 msec.)
10. Life-threatening illness where the subject is not expected to survive for 2 years or any history of cancer or malignancy within the past 5 years except for basal cell carcinoma or squamous cell carcinoma of the skin
11. A history of intolerance to probucol (Lorelco™)
12. Unreliability as a study participant based on the Investigator's (or designee's) knowledge of the subject (e.g., alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
13. Participation in any investigational drug study within 30 days prior to study entry, or expectation to participate in any other investigational drug study during the course of the ARISE study.
14. Previous participation in a study involving AGI-1067

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Length of time to the first occurrence of one of six adjudicated events: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for angina pectoris, or use of coronary revascularization.

Secondary Outcome Measures

Outcome Measure
Time to first incidence of any of the following: all cause mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, use of coronary revascularization, and hospitalization for unstable angina
Time to first incidence of any of the following: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina
Time to first incidence of any of the following: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, and non-fatal stroke

Collaborators and Investigators

• Sponsor: AtheroGenics
• Investigators: Study Chair: Marc A Pfeffer, MD, Cardiovascular Division Brigham and Women's Hospital; Study Chair: Jean-Claude Tardif, MD, Montreal Heart Institute; Principal Investigator: John McMurray, MD, Western Infirmary; Principal Investigator: Eric Klug, MD, Independent Medical Practitioner - South Africa

Publications and helpful links

General Publications

• Tardif JC, McMurray JJ, Klug E, Small R, Schumi J, Choi J, Cooper J, Scott R, Lewis EF, L'Allier PL, Pfeffer MA; Aggressive Reduction of Inflammation Stops Events (ARISE) Trial Investigators. Effects of succinobucol (AGI-1067) after an acute coronary syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 May 24;371(9626):1761-8. doi: 10.1016/S0140-6736(08)60763-1.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Study Completion: December 1, 2006

Study Registration Dates

• First Submitted: August 6, 2003
• First Submitted That Met QC Criteria: August 7, 2003
• First Posted (Estimate): August 8, 2003

Study Record Updates

• Last Update Posted (Estimate): October 3, 2006
• Last Update Submitted That Met QC Criteria: September 29, 2006
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: coronary artery disease; succinobucol; AGI-1067
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation; Atherosclerosis; Angina, Unstable
• Other Study ID Numbers: AGI-1067/042