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| Sponsor: | AtheroGenics |
|---|---|
| Information provided by: | AtheroGenics |
| ClinicalTrials.gov Identifier: | NCT00066898 |
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 III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: |
|
| Estimated Enrollment: | 6000 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | December 2006 |
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 |
IRB-approved informed written consent must be provided by all subjects prior to screening and study entry.
A. Inclusion Criteria
Male or female subjects in one of the two following groups:
(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%
B. Exclusion Criteria
Contacts and Locations
Hide Study 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 | |
| Hope Research Institute | |
| Phoenix, Arizona, United States | |
| Lovelace Scientific Resources | |
| Phoenix, Arizona, United States | |
| Tri City Cardiology Consultants | |
| Mesa, Arizona, United States | |
| Sonoran Health Specialists | |
| Scottsdale, Arizona, United States | |
| United States, California | |
| Escondido Cardiology | |
| Escondido, California, United States | |
| Orange County Research Cntr | |
| Orange, California, United States | |
| Capitol Interventional Cardiology | |
| Carmichael, California, United States | |
| Merced Heart Associates | |
| Merced, 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 | |
| SW Florida Heart Group | |
| Fort Myers, Florida, United States | |
| Clinical Research of West Florida, Inc. | |
| Tampa, Florida, United States | |
| Jacksonville Cntr Clin Research | |
| Jacksonville, Florida, United States | |
| Watson Clinic LLP | |
| Lakeland, 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 | |
| Univ of Florida, Cardiology | |
| Gainesville, Florida, United States | |
| Cardiovascular Research Center of South Florida | |
| Miami, Florida, United States | |
| Jacksonville Heart Center | |
| Jacksonville Beach, Florida, United States | |
| Diagnostic Cardiology | |
| Jacksonville, Florida, United States | |
| Clinical Research of West Florida, Inc. | |
| Clearwater, Florida, United States | |
| United States, Georgia | |
| Crawford Long Hospital | |
| Atlanta, Georgia, United States | |
| Emory University Hospital | |
| Atlanta, Georgia, United States | |
| Fuqua Hrt Cntr Piedmont Hosp | |
| Atlanta, Georgia, United States | |
| Harbin Clinic | |
| Rome, Georgia, United States | |
| United States, Idaho | |
| Idaho Cardiology Associates | |
| Boise, Idaho, United States | |
| United States, Illinois | |
| Heartcare Midwest Heart Inst | |
| Peoria, Illinois, United States | |
| Heart Care Research Foundation | |
| Blue Island, Illinois, United States | |
| Peryam and Kroll Healthcare | |
| Chicago, 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 | |
| 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 | |
| Cardiovascular Inst of South | |
| Thibodaux, Louisiana, United States | |
| Louisiana Clinical Trials | |
| New Orleans, Louisiana, United States | |
| Heart Clinic of Louisiana | |
| Marrero, Louisiana, United States | |
| Medical Research Institute | |
| Slidell, Louisiana, United States | |
| The Office of Dr. Richard Gilmore | |
| Lake Charles, Louisiana, United States | |
| United States, Maine | |
| Androscoggin Cardiology | |
| Auburn, Maine, United States | |
| United States, Maryland | |
| Midatlantic Cardiovascular | |
| Baltimore, Maryland, United States | |
| Midatlantic Cardiovascular | |
| Baltimore, Maryland, United States | |
| Midatlantic Cardiovascular Associates | |
| Baltimore, Maryland, United States | |
| Midatlantic Cardiovascular | |
| Baltimore, Maryland, United States | |
| Midatlantic Cardiovascular | |
| Baltimore, Maryland, United States | |
| Midatlantic Cardiovascular | |
| Bel Air, 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 | |
| Patuxent Medical Group | |
| Columbia, 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 | |
| The Office of Dr. Keith Pierce | |
| Livonia, Michigan, United States | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States | |
| Beaumont Medical Office Bldg | |
| Royal Oak, Michigan, United States | |
| Professional Clinical Research | |
| Cadillac, 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 | |
| St Louis Univ Div Solutions | |
| St Louis, Missouri, United States | |
| N'Touch Research | |
| Kansas City, Missouri, United States | |
| Washington Univ School of Med | |
| St Louis, Missouri, United States | |
| St Louis Univ Hospital | |
| St Louis, Missouri, United States | |
| United States, Nebraska | |
| Creighton Cardiac Center | |
| Omaha, Nebraska, United States | |
| Nebraska Heart Institute | |
| Papillion, Nebraska, United States | |
| Nebraska Heart Institute | |
| Lincoln, 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 | |
| Buffalo Cardiology and Pulmonary Associates | |
| Williamsville, New York, United States | |
| Syracuse Preventive Cardiology | |
| Syracuse, New York, United States | |
| United States, North Carolina | |
| Mid Carolina Cardiology Research Div | |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| Sterling Research Group | |
| Cincinnati, Ohio, United States | |
| Lindner Clinical Trial Center | |
| Cincinnati, Ohio, United States | |
| City Cardiology Associates | |
| Akron, Ohio, United States | |
| North Ohio Heart Center | |
| Sandusky, Ohio, United States | |
| New Horizons Clinical Research | |
| Cincinnati, Ohio, United States | |
| United States, Oklahoma | |
| Bluestem Cardiology | |
| Bartlesville, Oklahoma, United States | |
| Castlerock Clinical Research Consultants | |
| Tulsa, Oklahoma, United States | |
| COR Clinical Research, LLC | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| The Heart Care Group | |
| Allentown, Pennsylvania, United States | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States | |
| Banksville Medical | |
| Pittsburgh, Pennsylvania, United States | |
| Tri-State Medical Group | |
| Beaver, Pennsylvania, United States | |
| Kandra, Fierer, Kuskin Associates | |
| Harrisburg, 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 | |
| Cardiovascular Research Foundation | |
| Knoxville, Tennessee, United States | |
| Alpha Clinical Research | |
| Clarksville, Tennessee, United States | |
| United States, Texas | |
| Amarillo Heart Clinical Research Institute | |
| Amarillo, Texas, United States | |
| Austin Heart PA | |
| Austin, Texas, United States | |
| Research Clinic | |
| Nassau Bay, Texas, United States | |
| The Methodist Hospital | |
| Houston, Texas, United States | |
| Clinical Cardiovascular Research Cntr | |
| Dallas, Texas, United States | |
| Pharma Tex Research | |
| Amarillo, Texas, United States | |
| Sioco Cardiology, PA | |
| San Antonio, Texas, United States | |
| Southeast Texas Cardiology Associates II | |
| Beaumont, 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 | |
| St Joseph Health Care Hamilton | |
| Hamilton, Ontario, Canada | |
| Kingston Heart Clinic | |
| Kingston, Ontario, Canada | |
| London Health Sci Cntr Site | |
| 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 | |
| Cliks Medical Research | |
| Thunder Bay, Ontario, Canada | |
| The Office of Dr. Syan Gurcharan | |
| Sudbury, 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 | |
| Mount St. Joseph's | |
| London, Ontario, Canada | |
| Halton Heart Institute | |
| Burlington, Ontario, Canada | |
| Thunder Bay Regional Health Science Ctr | |
| Thunder Bay, Ontario, Canada | |
| Canada, Quebec | |
| Laval Hospital Pavillion 2U | |
| Ste-Foy, Quebec, Canada | |
| Q & T Research Outaouais | |
| Gatineau, Quebec, Canada | |
| Recherches Cliniques Theradev | |
| Granby, Quebec, Canada | |
| ViaCar Recherche Clinique | |
| 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 | |
| McGill Univ Health Cntr | |
| Montreal, Quebec, Canada | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada | |
| CUSM Montreal General Hosp | |
| Montreal, Quebec, Canada | |
| Hopital du Sacre Coeur De Montreal | |
| Montreal, Quebec, Canada | |
| Maisonneuve Rosemont Hosp | |
| Montreal, Quebec, Canada | |
| Cntr Hospitalier Pierre Le Gardeur | |
| Terrebonne, Quebec, Canada | |
| CMGC-GRID Complexe Hosp | |
| Chicoutimi, Quebec, Canada | |
| Cntr Hospital Beauce Etchemin | |
| St. George, Quebec, Canada | |
| Reseau Sante Richelieu Yamaska | |
| Saint Hyacinthe, Quebec, Canada | |
| Hopital du Haut-Richelieu | |
| St.-Jean sur Richelieu, Quebec, Canada | |
| Zoom International | |
| Saint Jerome, Quebec, Canada | |
| London Clinical Research | |
| Sherbrooke, Quebec, Canada | |
| Centre Hospitalier de Val d'Or | |
| Val d'Or, Quebec, Canada | |
| Societe des internistes Bois Fran | |
| Victoriaville, Quebec, Canada | |
| ViaCar Recherche Clinique Inc. | |
| Longueuil, Quebec, Canada | |
| Neufort Inc. | |
| Saint-Lambert, Quebec, Canada | |
| CHUM Hopital Notre Dame | |
| Montreal, Quebec, Canada | |
| The Office of Dr. Jean-Robert Timothee | |
| Greenfield Park, Quebec, Canada | |
| Medi-Recherche Inc. | |
| Montreal, Quebec, Canada | |
| Recherches Clinicar | |
| Quebec City, Quebec, Canada | |
| Medicayeb, Inc. | |
| Longueuil, 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, BLM | |
| Universitas Hospital | |
| Bloemfontein, BLM, South Africa | |
| Dr. Johann Viljoen | |
| Bloemfontein, BLM, South Africa | |
| Fichmed 5, Rosepark Hospital | |
| Bloemfontein, BLM, South Africa | |
| South Africa, CT | |
| Panorama Medical 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 | |
| 228 Panorama Medi Clinic | |
| Panorama, CT, South Africa | |
| South Africa, DBN | |
| Chatsmed Garden Hospital | |
| Chatsworth, DBN, South Africa | |
| Chatsmed Hospital | |
| Chatsworth, DBN, South Africa | |
| 403 Maxwell Centre | |
| Durban, DBN, South Africa | |
| South Africa, JHB | |
| United House | |
| Fordsburg, JHB, South Africa | |
| The Boulders Shopping Center | |
| Halfway House, JHB, South Africa | |
| Olivedale Clinic | |
| Olivedale, JHB, South Africa | |
| Sunninghill Hospital | |
| Sunninghill,, JHB, South Africa | |
| Sunninghill Hospital | |
| Sunninghill,, JHB, South Africa | |
| Mulbarton Medical Center | |
| Mulbarton, JHB, South Africa | |
| South Africa, PTA | |
| Pretoria Heart Hospital | |
| Arcadia, PTA, South Africa | |
| Unitas Hospital | |
| Lyttelton Centurion, PTA, South Africa | |
| Wilgers Medical Consortium | |
| The Willows, PTA, South Africa | |
| United Kingdom | |
| Grampian University Hospitals NHS Trust | |
| Aberdeen, United Kingdom | |
| Sandwell & West Birmingham City Hospital NHS Trust | |
| Birmingham, United Kingdom | |
| Mid Yorkshire Hospitals | |
| Wakefield, United Kingdom | |
| Forth Valley Acute Hospitals NHS Trust | |
| Stirling, United Kingdom | |
| The Lothian University Hospitals NHS Trust | |
| Edinburgh, United Kingdom | |
| Sheffield Teaching Hospitals NHS Trust | |
| Sheffield, United Kingdom | |
| Liverpool NHS Trust | |
| Liverpool, United Kingdom | |
| North Glasglow University Hospitals NHS Trust | |
| Glasglow, United Kingdom | |
| Argyll & Clyde NHS Trust | |
| Paisley, United Kingdom | |
| South Glasglow University Hospital NHS Trust | |
| Glasglow, United Kingdom | |
| Western Infirmary Glaglow | |
| Glasglow, United Kingdom | |
| University Hospitals of Leicester NHS Trust | |
| Leicester, United Kingdom | |
| University Hospitals of North Staffordshire NHS Trust | |
| Stok-on-Trent, United Kingdom | |
| South Manchester University Hospitals NHS Trust | |
| Manchester, United Kingdom | |
| Papworth Hospital NHS Trust | |
| Cambridge, United Kingdom | |
| The Leeds Teaching Hospitals NHS Trust | |
| Leeds, United Kingdom | |
| Sheffield Teaching Hospitals NHS Trust | |
| Sheffield, United Kingdom | |
| United Kingdom, England | |
| King's College Hospital NHS Trust | |
| London, England, United Kingdom | |
| United Kingdom, Essex | |
| Barking, Havering & Redbridge Hospital NHS Trust | |
| Romford, Essex, United Kingdom | |
| 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
| Study ID Numbers: | AGI-1067/042 |
| Study First Received: | August 6, 2003 |
| Last Updated: | September 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00066898 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Canada: Health Canada; South Africa: Medicines Control Council |
|
succinobucol AGI-1067 coronary artery disease |
|
Arterial Occlusive Diseases Atherosclerosis Heart Diseases Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Ischemia Arteriosclerosis Inflammation |
Chest Pain Coronary Disease Signs and Symptoms Necrosis Pathologic Processes Cardiovascular Diseases Infarction Angina, Unstable Myocardial Infarction Coronary Artery Disease |