Clinical trial NCT00066898: ARISE - Aggressive Reduction of Inflammation Stops Events
Official title: "Reduction of Vascular Inflammation and Coronary Atherosclerosis With AGI-1067, a V-Protectant, Reduces Cardiovascular Events in Patients With Coronary Artery Disease"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atherosclerosis
Coronary Artery Disease
Myocardial Infarction
Unstable Angina
Keywords: succinobucol
AGI-1067
coronary artery disease
Lead sponsor: AtheroGenics
Sponsor class: INDUSTRY
First posted: 2003-08-08
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

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