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	Treatment or Intervention	Phase
Atherosclerosis Coronary Artery Disease Myocardial Infarction Unstable Angina	Drug: AGI-1067	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Subjects with a recent diagnosis of coronary artery disease.

AND:

• Male or female aged 55 years or older with additional risk factors.
• Male or female diabetics aged 18 years or older.
• Females must be non-lactating and not of child bearing potential (post-menopausal or surgically sterilized) or must use a reliable method of birth control considered suitable by the Investigator.

Sineth Desai      714-210-6660    sdesai@integrium.com

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

Study ID Numbers:  AGI-1067/042
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066898
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08