ARISE – Aggressive Reduction of Inflammation Stops Events

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by AtheroGenics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
AtheroGenics
ClinicalTrials.gov Identifier:
NCT00066898
First received: August 6, 2003
Last updated: September 29, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Coronary Artery Disease
Myocardial Infarction
Unstable Angina
Drug: AGI-1067
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: “Reduction of Vascular Inflammation and Coronary Atherosclerosis With AGI-1067, a V-Protectant, Reduces Cardiovascular Events in Patients With Coronary Artery Disease”

Resource links provided by NLM:


Further study details as provided by AtheroGenics:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 6000
Study Start Date: June 2003
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00066898

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

No publications provided by AtheroGenics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00066898     History of Changes
Other Study ID Numbers: AGI-1067/042
Study First Received: August 6, 2003
Last Updated: September 29, 2006
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
South Africa: Medicines Control Council

Keywords provided by AtheroGenics:
succinobucol
AGI-1067
coronary artery disease

Additional relevant MeSH terms:
Angina, Unstable
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Inflammation
Myocardial Infarction
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 28, 2014