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ARISE - Aggressive Reduction of Inflammation Stops Events

Primary Purpose

Atherosclerosis, Coronary Artery Disease, Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AGI-1067
Sponsored by
AtheroGenics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring succinobucol, AGI-1067, coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

IRB-approved informed written consent must be provided by all subjects prior to screening and study entry. A. Inclusion Criteria Informed written consent from the subject prior to Screening Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization Male or female subjects in one of the two following groups: Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older 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% Females must be non-lactating and not of child bearing potential B. Exclusion Criteria Subjects who are hemodynamically or clinically unstable Subjects who have had a PCI in the last 30 days Subjects who have had coronary artery bypass (CABG) in the last 3 months Subjects on a waiting list for revascularization or revascularization already planned Current symptoms consistent with moderate or severe CHF despite medical therapy Clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy Uncontrolled hypertension (e.g., sitting systolic BP > 180 mm Hg on antihypertensive therapy) Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction 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.) 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 A history of intolerance to probucol (Lorelco™) 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) 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. Previous participation in a study involving AGI-1067

Sites / Locations

  • Cardiovascular Associates
  • Univ of Alabama at Birmingham
  • The Heart Center/Oracle Research
  • Tri City Cardiology Consultants
  • Tri-City Cardiology Consultants
  • Hope Research Institute
  • Lovelace Scientific Resources
  • Sonoran Health Specialists
  • Capitol Interventional Cardiology
  • Escondido Cardiology
  • Merced Heart Associates
  • Orange County Research Cntr
  • ARI Clinical Trials
  • Radiant Research
  • Pikes Peak Cardiology
  • Aurora Denver Cardiololgy Associates
  • Heart and Vascular Clinic N CO
  • Connecticut Clinical Research
  • Cardiac Specialists, PC
  • Christiana Care Health Svcs
  • Clinical Research of West Florida, Inc.
  • SW Florida Heart Group
  • Univ of Florida, Cardiology
  • Jacksonville Heart Center
  • Diagnostic Cardiology
  • Jacksonville Cntr Clin Research
  • Watson Clinic LLP
  • Cardiovascular Research Center of South Florida
  • Orlando Heart Cntr
  • Cardiovascular Cntr of Sarasota
  • The Broward Heart Group
  • Clinical Research of West Florida, Inc.
  • Crawford Long Hospital
  • Emory University Hospital
  • Fuqua Hrt Cntr Piedmont Hosp
  • Harbin Clinic
  • Idaho Cardiology Associates
  • Heart Care Research Foundation
  • Peryam and Kroll Healthcare
  • Heartcare Midwest Heart Inst
  • The Heart Group
  • Welborn Clinic Research Center
  • Parkview Hospital
  • Care Group St. Vincent Hosp of IN
  • Research Inst of Middle America
  • Iowa Heart Center
  • Univ of IA College of Medicine
  • Research Inst of Kansas Inc
  • Cardiovascular Associates
  • Louisiana Heart Center
  • The Office of Dr. Richard Gilmore
  • Heart Clinic of Louisiana
  • Cardiovascular Inst of the South
  • Cardiovascular Inst of the South
  • Louisiana Clinical Trials
  • Tulane Univ Medical Center
  • Medical Research Institute
  • Cardiovascular Inst of South
  • Androscoggin Cardiology
  • Midatlantic Cardiovascular Associates
  • Midatlantic Cardiovascular
  • Midatlantic Cardiovascular
  • Patuxent Medical Group
  • MD Med Research Ong Med Cntr
  • Midatlantic Cardiovascular
  • Midatlantic Cardiovascular
  • Compass Medical Associates
  • Gary Brockington, MD
  • Lahey Clinic Med Cntr
  • Pentucket Med Assoc Inc
  • Charles River Med Associates
  • Professional Clinical Research
  • Borgess Medical Center
  • The Office of Dr. Keith Pierce
  • Beaumont Medical Office Bldg
  • Michigan Heart Group
  • St Paul Heart Clinic
  • N'Touch Research
  • St Louis Univ Div Solutions
  • St Louis Univ Hospital
  • Washington Univ School of Med
  • Nebraska Heart Institute
  • Creighton Cardiac Center
  • Nebraska Heart Institute
  • Cardiovascular Assoc of Delaware Valley
  • Cardiovascular Associates of the Delaware Valley
  • SUNY Downstate Health Science Ctr
  • St Vincent's Med Cntr NY
  • SUNY Upstate Medical Univ
  • Syracuse Preventive Cardiology
  • Buffalo Cardiology and Pulmonary Associates
  • Mid Carolina Cardiology Research Div
  • City Cardiology Associates
  • Lindner Clinical Trial Center
  • New Horizons Clinical Research
  • Sterling Research Group
  • North Ohio Heart Center
  • Bluestem Cardiology
  • COR Clinical Research, LLC
  • Castlerock Clinical Research Consultants
  • The Heart Care Group
  • Tri-State Medical Group
  • Geisinger Medical Center
  • Kandra, Fierer, Kuskin Associates
  • Allegheny General Hospital
  • Banksville Medical
  • Rhode Island Cardiovascular Group
  • Charleston Cardiology
  • Internal Medicine of Greer
  • Alpha Clinical Research
  • Cardiovascular Research Foundation
  • Amarillo Heart Clinical Research Institute
  • Pharma Tex Research
  • Austin Heart PA
  • Southeast Texas Cardiology Associates II
  • Clinical Cardiovascular Research Cntr
  • The Methodist Hospital
  • Research Clinic
  • Sioco Cardiology, PA
  • Heart Center
  • IHC Health Services
  • DUCCS Research of S Boston
  • Daniel Gottlieb MD PS
  • U of WA NW Lipid Research Cntr
  • Appleton Heart Inst
  • Wisconsin Center for Clinical Research
  • Medical College of Wisconsin
  • Allegiance Research Specialists
  • Foothills Hospital Cardiology Div
  • Royal Alexandra Hospital
  • West Coast Cardiology Research
  • Vancouver General Hospital
  • Health Sciences Centre
  • St Boniface General Hospital
  • Health Sciences Centre Div of Cardiology
  • Queen Elizabeth Health Sciences Centre
  • Halton Heart Institute
  • St Joseph Health Care Hamilton
  • Kingston Heart Clinic
  • London Health Sci Cntr Site
  • Mount St. Joseph's
  • Newmarket Cardiology Research
  • Heart Care Research
  • Ottawa Cardiovascular Center
  • Vexler Health Services
  • The Office of Dr. Syan Gurcharan
  • Cliks Medical Research
  • Thunder Bay Regional Health Science Ctr
  • Mount Sinai Hospital
  • Sunnybrook and Women's College
  • University Health Network - Toronto Western Hosp
  • CMGC-GRID Complexe Hosp
  • Q & T Research Outaouais
  • Recherches Cliniques Theradev
  • The Office of Dr. Jean-Robert Timothee
  • ViaCar Recherche Clinique
  • Hosp Regional de Lanaudiere
  • Cite de la Sante de Laval
  • Clinique de Cardiologie de Levis
  • Medicayeb, Inc.
  • ViaCar Recherche Clinique Inc.
  • CHUM Hopital Notre Dame
  • CUSM Montreal General Hosp
  • Hopital du Sacre Coeur De Montreal
  • Maisonneuve Rosemont Hosp
  • McGill Univ Health Cntr
  • Medi-Recherche Inc.
  • Montreal Heart Institute
  • Recherches Clinicar
  • Reseau Sante Richelieu Yamaska
  • Zoom International
  • Neufort Inc.
  • London Clinical Research
  • Cntr Hospital Beauce Etchemin
  • Hopital du Haut-Richelieu
  • Laval Hospital Pavillion 2U
  • Cntr Hospitalier Pierre Le Gardeur
  • Centre Hospitalier de Val d'Or
  • Societe des internistes Bois Fran
  • Pasqua Hosp Coronary Care Unit
  • Royal University Hospital
  • Saskatoon Medical Specialists
  • Dr. Johann Viljoen
  • Fichmed 5, Rosepark Hospital
  • Universitas Hospital
  • 228 Panorama Medi Clinic
  • Panorama Medical Clinic
  • Tygerberg Hospital
  • Vincent Pallotti Hospital
  • Vergelegen Medical Clinic
  • Chatsmed Garden Hospital
  • Chatsmed Hospital
  • 403 Maxwell Centre
  • United House
  • The Boulders Shopping Center
  • Mulbarton Medical Center
  • Olivedale Clinic
  • Sunninghill Hospital
  • Pretoria Heart Hospital
  • Unitas Hospital
  • Wilgers Medical Consortium
  • King's College Hospital NHS Trust
  • Barking, Havering & Redbridge Hospital NHS Trust
  • Grampian University Hospitals NHS Trust
  • Sandwell & West Birmingham City Hospital NHS Trust
  • Papworth Hospital NHS Trust
  • The Lothian University Hospitals NHS Trust
  • North Glasglow University Hospitals NHS Trust
  • South Glasglow University Hospital NHS Trust
  • Western Infirmary Glaglow
  • The Leeds Teaching Hospitals NHS Trust
  • University Hospitals of Leicester NHS Trust
  • Liverpool NHS Trust
  • South Manchester University Hospitals NHS Trust
  • Argyll & Clyde NHS Trust
  • Sheffield Teaching Hospitals NHS Trust
  • Forth Valley Acute Hospitals NHS Trust
  • University Hospitals of North Staffordshire NHS Trust
  • Mid Yorkshire Hospitals

Outcomes

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

Full Information

First Posted
August 6, 2003
Last Updated
September 29, 2006
Sponsor
AtheroGenics
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1. Study Identification

Unique Protocol Identification Number
NCT00066898
Brief Title
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

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AtheroGenics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Coronary Artery Disease, Myocardial Infarction, Unstable Angina
Keywords
succinobucol, AGI-1067, coronary artery disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
6000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AGI-1067
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Time to first incidence of any of the following: cardiovascular mortality, resuscitated cardiac arrest, non-fatal MI, and non-fatal stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
IRB-approved informed written consent must be provided by all subjects prior to screening and study entry. A. Inclusion Criteria Informed written consent from the subject prior to Screening Acute MI or unstable angina not less than 14 days and not more than one year prior to randomization Male or female subjects in one of the two following groups: Subjects with diabetes mellitus (NIDDM or IDDM) 18 years of age or older 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% Females must be non-lactating and not of child bearing potential B. Exclusion Criteria Subjects who are hemodynamically or clinically unstable Subjects who have had a PCI in the last 30 days Subjects who have had coronary artery bypass (CABG) in the last 3 months Subjects on a waiting list for revascularization or revascularization already planned Current symptoms consistent with moderate or severe CHF despite medical therapy Clinically significant valvular heart disease or Hypertrophic Obstructive Cardiomyopathy Uncontrolled hypertension (e.g., sitting systolic BP > 180 mm Hg on antihypertensive therapy) Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction 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.) 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 A history of intolerance to probucol (Lorelco™) 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) 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. Previous participation in a study involving AGI-1067
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Pfeffer, MD
Organizational Affiliation
Cardiovascular Division Brigham and Women's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jean-Claude Tardif, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John McMurray, MD
Organizational Affiliation
Western Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Klug, MD
Organizational Affiliation
Independent Medical Practitioner - South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Associates
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
The Heart Center/Oracle Research
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Tri City Cardiology Consultants
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Tri-City Cardiology Consultants
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Lovelace Scientific Resources
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Sonoran Health Specialists
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Capitol Interventional Cardiology
City
Carmichael
State/Province
California
Country
United States
Facility Name
Escondido Cardiology
City
Escondido
State/Province
California
Country
United States
Facility Name
Merced Heart Associates
City
Merced
State/Province
California
Country
United States
Facility Name
Orange County Research Cntr
City
Orange
State/Province
California
Country
United States
Facility Name
ARI Clinical Trials
City
Redondo Beach
State/Province
California
Country
United States
Facility Name
Radiant Research
City
Santa Rosa
State/Province
California
Country
United States
Facility Name
Pikes Peak Cardiology
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Aurora Denver Cardiololgy Associates
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Heart and Vascular Clinic N CO
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
Connecticut Clinical Research
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
Cardiac Specialists, PC
City
Trumbull
State/Province
Connecticut
Country
United States
Facility Name
Christiana Care Health Svcs
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
SW Florida Heart Group
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Univ of Florida, Cardiology
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Jacksonville Heart Center
City
Jacksonville Beach
State/Province
Florida
Country
United States
Facility Name
Diagnostic Cardiology
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Jacksonville Cntr Clin Research
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Watson Clinic LLP
City
Lakeland
State/Province
Florida
Country
United States
Facility Name
Cardiovascular Research Center of South Florida
City
Miami
State/Province
Florida
Country
United States
Facility Name
Orlando Heart Cntr
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Cardiovascular Cntr of Sarasota
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
The Broward Heart Group
City
Tamarac
State/Province
Florida
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Crawford Long Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Fuqua Hrt Cntr Piedmont Hosp
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Harbin Clinic
City
Rome
State/Province
Georgia
Country
United States
Facility Name
Idaho Cardiology Associates
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Heart Care Research Foundation
City
Blue Island
State/Province
Illinois
Country
United States
Facility Name
Peryam and Kroll Healthcare
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Heartcare Midwest Heart Inst
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
The Heart Group
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Welborn Clinic Research Center
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Care Group St. Vincent Hosp of IN
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Inst of Middle America
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
Country
United States
Facility Name
Univ of IA College of Medicine
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Research Inst of Kansas Inc
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Cardiovascular Associates
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Louisiana Heart Center
City
Chalmette
State/Province
Louisiana
Country
United States
Facility Name
The Office of Dr. Richard Gilmore
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Heart Clinic of Louisiana
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
Cardiovascular Inst of the South
City
Morgan City
State/Province
Louisiana
Country
United States
Facility Name
Cardiovascular Inst of the South
City
New Iberia
State/Province
Louisiana
Country
United States
Facility Name
Louisiana Clinical Trials
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Tulane Univ Medical Center
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Medical Research Institute
City
Slidell
State/Province
Louisiana
Country
United States
Facility Name
Cardiovascular Inst of South
City
Thibodaux
State/Province
Louisiana
Country
United States
Facility Name
Androscoggin Cardiology
City
Auburn
State/Province
Maine
Country
United States
Facility Name
Midatlantic Cardiovascular Associates
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Midatlantic Cardiovascular
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Midatlantic Cardiovascular
City
Bel Air
State/Province
Maryland
Country
United States
Facility Name
Patuxent Medical Group
City
Columbia
State/Province
Maryland
Country
United States
Facility Name
MD Med Research Ong Med Cntr
City
Oxon Hill
State/Province
Maryland
Country
United States
Facility Name
Midatlantic Cardiovascular
City
Towson
State/Province
Maryland
Country
United States
Facility Name
Midatlantic Cardiovascular
City
Westminster
State/Province
Maryland
Country
United States
Facility Name
Compass Medical Associates
City
Abington
State/Province
Massachusetts
Country
United States
Facility Name
Gary Brockington, MD
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Lahey Clinic Med Cntr
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
Pentucket Med Assoc Inc
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
Charles River Med Associates
City
Natick
State/Province
Massachusetts
Country
United States
Facility Name
Professional Clinical Research
City
Cadillac
State/Province
Michigan
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
The Office of Dr. Keith Pierce
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
Beaumont Medical Office Bldg
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Michigan Heart Group
City
Troy
State/Province
Michigan
Country
United States
Facility Name
St Paul Heart Clinic
City
St Paul
State/Province
Minnesota
Country
United States
Facility Name
N'Touch Research
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
St Louis Univ Div Solutions
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
St Louis Univ Hospital
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
Washington Univ School of Med
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
Country
United States
Facility Name
Creighton Cardiac Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Nebraska Heart Institute
City
Papillion
State/Province
Nebraska
Country
United States
Facility Name
Cardiovascular Assoc of Delaware Valley
City
Elmer
State/Province
New Jersey
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Haddon Heights
State/Province
New Jersey
Country
United States
Facility Name
SUNY Downstate Health Science Ctr
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
St Vincent's Med Cntr NY
City
New York
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical Univ
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Syracuse Preventive Cardiology
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Buffalo Cardiology and Pulmonary Associates
City
Williamsville
State/Province
New York
Country
United States
Facility Name
Mid Carolina Cardiology Research Div
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
City Cardiology Associates
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
North Ohio Heart Center
City
Sandusky
State/Province
Ohio
Country
United States
Facility Name
Bluestem Cardiology
City
Bartlesville
State/Province
Oklahoma
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Castlerock Clinical Research Consultants
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
The Heart Care Group
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Tri-State Medical Group
City
Beaver
State/Province
Pennsylvania
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
Country
United States
Facility Name
Kandra, Fierer, Kuskin Associates
City
Harrisburg
State/Province
Pennsylvania
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Banksville Medical
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Rhode Island Cardiovascular Group
City
Woonsocket
State/Province
Rhode Island
Country
United States
Facility Name
Charleston Cardiology
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Internal Medicine of Greer
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Alpha Clinical Research
City
Clarksville
State/Province
Tennessee
Country
United States
Facility Name
Cardiovascular Research Foundation
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Amarillo Heart Clinical Research Institute
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Pharma Tex Research
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Austin Heart PA
City
Austin
State/Province
Texas
Country
United States
Facility Name
Southeast Texas Cardiology Associates II
City
Beaumont
State/Province
Texas
Country
United States
Facility Name
Clinical Cardiovascular Research Cntr
City
Dallas
State/Province
Texas
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Clinic
City
Nassau Bay
State/Province
Texas
Country
United States
Facility Name
Sioco Cardiology, PA
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Heart Center
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
IHC Health Services
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
DUCCS Research of S Boston
City
South Boston
State/Province
Virginia
Country
United States
Facility Name
Daniel Gottlieb MD PS
City
Burien
State/Province
Washington
Country
United States
Facility Name
U of WA NW Lipid Research Cntr
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Appleton Heart Inst
City
Appleton
State/Province
Wisconsin
Country
United States
Facility Name
Wisconsin Center for Clinical Research
City
Elkhorn
State/Province
Wisconsin
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Allegiance Research Specialists
City
Wauwatosa
State/Province
Wisconsin
Country
United States
Facility Name
Foothills Hospital Cardiology Div
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
West Coast Cardiology Research
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
St Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Health Sciences Centre Div of Cardiology
City
St. Johns
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Queen Elizabeth Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Halton Heart Institute
City
Burlington
State/Province
Ontario
Country
Canada
Facility Name
St Joseph Health Care Hamilton
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Kingston Heart Clinic
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
London Health Sci Cntr Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Mount St. Joseph's
City
London
State/Province
Ontario
Country
Canada
Facility Name
Newmarket Cardiology Research
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Heart Care Research
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Cardiovascular Center
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Vexler Health Services
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
The Office of Dr. Syan Gurcharan
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Cliks Medical Research
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Thunder Bay Regional Health Science Ctr
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook and Women's College
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network - Toronto Western Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CMGC-GRID Complexe Hosp
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Q & T Research Outaouais
City
Gatineau
State/Province
Quebec
Country
Canada
Facility Name
Recherches Cliniques Theradev
City
Granby
State/Province
Quebec
Country
Canada
Facility Name
The Office of Dr. Jean-Robert Timothee
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
ViaCar Recherche Clinique
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Hosp Regional de Lanaudiere
City
Joliette
State/Province
Quebec
Country
Canada
Facility Name
Cite de la Sante de Laval
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Clinique de Cardiologie de Levis
City
Levis
State/Province
Quebec
Country
Canada
Facility Name
Medicayeb, Inc.
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
ViaCar Recherche Clinique Inc.
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
CHUM Hopital Notre Dame
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CUSM Montreal General Hosp
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hopital du Sacre Coeur De Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Maisonneuve Rosemont Hosp
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill Univ Health Cntr
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Medi-Recherche Inc.
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Recherches Clinicar
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Reseau Sante Richelieu Yamaska
City
Saint Hyacinthe
State/Province
Quebec
Country
Canada
Facility Name
Zoom International
City
Saint Jerome
State/Province
Quebec
Country
Canada
Facility Name
Neufort Inc.
City
Saint-Lambert
State/Province
Quebec
Country
Canada
Facility Name
London Clinical Research
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Cntr Hospital Beauce Etchemin
City
St. George
State/Province
Quebec
Country
Canada
Facility Name
Hopital du Haut-Richelieu
City
St.-Jean sur Richelieu
State/Province
Quebec
Country
Canada
Facility Name
Laval Hospital Pavillion 2U
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
Cntr Hospitalier Pierre Le Gardeur
City
Terrebonne
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier de Val d'Or
City
Val d'Or
State/Province
Quebec
Country
Canada
Facility Name
Societe des internistes Bois Fran
City
Victoriaville
State/Province
Quebec
Country
Canada
Facility Name
Pasqua Hosp Coronary Care Unit
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Saskatoon Medical Specialists
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Dr. Johann Viljoen
City
Bloemfontein
State/Province
BLM
Country
South Africa
Facility Name
Fichmed 5, Rosepark Hospital
City
Bloemfontein
State/Province
BLM
Country
South Africa
Facility Name
Universitas Hospital
City
Bloemfontein
State/Province
BLM
Country
South Africa
Facility Name
228 Panorama Medi Clinic
City
Panorama
State/Province
CT
Country
South Africa
Facility Name
Panorama Medical Clinic
City
Panorama
State/Province
CT
Country
South Africa
Facility Name
Tygerberg Hospital
City
Parow
State/Province
CT
Country
South Africa
Facility Name
Vincent Pallotti Hospital
City
Pinelands
State/Province
CT
Country
South Africa
Facility Name
Vergelegen Medical Clinic
City
Somerset West
State/Province
CT
Country
South Africa
Facility Name
Chatsmed Garden Hospital
City
Chatsworth
State/Province
DBN
Country
South Africa
Facility Name
Chatsmed Hospital
City
Chatsworth
State/Province
DBN
Country
South Africa
Facility Name
403 Maxwell Centre
City
Durban
State/Province
DBN
Country
South Africa
Facility Name
United House
City
Fordsburg
State/Province
JHB
Country
South Africa
Facility Name
The Boulders Shopping Center
City
Halfway House
State/Province
JHB
Country
South Africa
Facility Name
Mulbarton Medical Center
City
Mulbarton
State/Province
JHB
Country
South Africa
Facility Name
Olivedale Clinic
City
Olivedale
State/Province
JHB
Country
South Africa
Facility Name
Sunninghill Hospital
City
Sunninghill,
State/Province
JHB
Country
South Africa
Facility Name
Pretoria Heart Hospital
City
Arcadia
State/Province
PTA
Country
South Africa
Facility Name
Unitas Hospital
City
Lyttelton Centurion
State/Province
PTA
Country
South Africa
Facility Name
Wilgers Medical Consortium
City
The Willows
State/Province
PTA
Country
South Africa
Facility Name
King's College Hospital NHS Trust
City
London
State/Province
England
Country
United Kingdom
Facility Name
Barking, Havering & Redbridge Hospital NHS Trust
City
Romford
State/Province
Essex
Country
United Kingdom
Facility Name
Grampian University Hospitals NHS Trust
City
Aberdeen
Country
United Kingdom
Facility Name
Sandwell & West Birmingham City Hospital NHS Trust
City
Birmingham
Country
United Kingdom
Facility Name
Papworth Hospital NHS Trust
City
Cambridge
Country
United Kingdom
Facility Name
The Lothian University Hospitals NHS Trust
City
Edinburgh
Country
United Kingdom
Facility Name
North Glasglow University Hospitals NHS Trust
City
Glasglow
Country
United Kingdom
Facility Name
South Glasglow University Hospital NHS Trust
City
Glasglow
Country
United Kingdom
Facility Name
Western Infirmary Glaglow
City
Glasglow
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom
Facility Name
Liverpool NHS Trust
City
Liverpool
Country
United Kingdom
Facility Name
South Manchester University Hospitals NHS Trust
City
Manchester
Country
United Kingdom
Facility Name
Argyll & Clyde NHS Trust
City
Paisley
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Trust
City
Sheffield
Country
United Kingdom
Facility Name
Forth Valley Acute Hospitals NHS Trust
City
Stirling
Country
United Kingdom
Facility Name
University Hospitals of North Staffordshire NHS Trust
City
Stok-on-Trent
Country
United Kingdom
Facility Name
Mid Yorkshire Hospitals
City
Wakefield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18502300
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.
Results Reference
derived

Learn more about this trial

ARISE - Aggressive Reduction of Inflammation Stops Events

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