- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01088503
Tratamiento con inhibidores del receptor de adenosina difosfato (ADP): evaluación longitudinal de patrones de tratamiento y eventos después del síndrome coronario agudo (TRANSLATE-ACS)
El estudio TRANSLATE-ACS: tratamiento con inhibidores del receptor de ADP: evaluación longitudinal de patrones de tratamiento y eventos después del síndrome coronario agudo
El estudio TRANSLATE-ACS (Treatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome) es un estudio observacional longitudinal prospectivo para evaluar la efectividad y el uso en el mundo real de prasugrel y otras terapias con inhibidores del receptor de ADP en pacientes con infarto de miocardio. (MI) participantes tratados con intervención coronaria percutánea (ICP) durante la hospitalización índice. Las decisiones de manejo y tratamiento de los participantes quedan a discreción del equipo de atención según la práctica clínica de rutina. Aproximadamente 17,000 participantes se inscribirán en aproximadamente 350 sitios en los Estados Unidos. El seguimiento se realizará durante 15 meses en aproximadamente 15.650 participantes.
TRANSLATE-ACS complementará los resultados de los ensayos clínicos controlados aleatorios y los registros actuales para abordar los patrones de tratamiento del mundo real y los resultados clínicos para los participantes con IM tratados con PCI e iniciados en la terapia con inhibidores del receptor de ADP. Además de determinar la eficacia de prasugrel en comparación con otros inhibidores del receptor de ADP, el estudio también determinará los factores asociados con la selección inicial del inhibidor del receptor de ADP y los patrones longitudinales de uso, evaluará la seguridad y describirá y comparará el uso de recursos y los costos médicos asociados con Inhibidores de los receptores de ADP. Además, este estudio generará un continuo de información desde los entornos de pacientes hospitalizados hasta los ambulatorios para proporcionar una imagen completa del tratamiento de los participantes y los resultados que actualmente no están disponibles para los nuevos inhibidores de los receptores de ADP.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
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Mobile, Alabama, Estados Unidos, 36617
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Alaska
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Anchorage, Alaska, Estados Unidos, 99508
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Fayetteville, Alaska, Estados Unidos, 72703
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Arizona
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Gilbert, Arizona, Estados Unidos, 85297
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Scottsdale, Arizona, Estados Unidos, 85258
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Tucson, Arizona, Estados Unidos, 85723
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Arkansas
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Fort Smith, Arkansas, Estados Unidos, 72901
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Little Rock, Arkansas, Estados Unidos, 72205
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Rogers, Arkansas, Estados Unidos, 72758
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California
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Berkeley, California, Estados Unidos, 94705
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Loma Linda, California, Estados Unidos, 92354
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Newport Beach, California, Estados Unidos, 92663
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Northridge, California, Estados Unidos, 91325
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Roseville, California, Estados Unidos, 95661
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Sacramento, California, Estados Unidos, 95819
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Salinas, California, Estados Unidos, 93901
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Santa Barbara, California, Estados Unidos, 93105
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Stockton, California, Estados Unidos, 95204
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Thousand Oaks, California, Estados Unidos, 91360
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Torrance, California, Estados Unidos, 90505
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
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Parker, Colorado, Estados Unidos, 80138
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Connecticut
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Bridgeport, Connecticut, Estados Unidos, 06610
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Danbury, Connecticut, Estados Unidos, 06810
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Farmington, Connecticut, Estados Unidos, 06030
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Hartford, Connecticut, Estados Unidos, 06102
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Delaware
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Newark, Delaware, Estados Unidos, 19718
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010
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Florida
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Atlantis, Florida, Estados Unidos, 33462
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Brandon, Florida, Estados Unidos, 33511
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Ft Lauderdale, Florida, Estados Unidos, 33308
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Gainesville, Florida, Estados Unidos, 32608
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Hudson, Florida, Estados Unidos, 34667
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Jacksonville, Florida, Estados Unidos, 32209
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Lakeland, Florida, Estados Unidos, 33805
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Melbourne, Florida, Estados Unidos, 32901
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Miami Beach, Florida, Estados Unidos, 33140
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Ocala, Florida, Estados Unidos, 34471
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Orlando, Florida, Estados Unidos, 32806
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Stuart, Florida, Estados Unidos, 34996
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Tampa, Florida, Estados Unidos, 33613
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Vero Beach, Florida, Estados Unidos, 32960
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Wellington, Florida, Estados Unidos, 33449
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Winter Haven, Florida, Estados Unidos, 33881
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Georgia
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Columbus, Georgia, Estados Unidos, 31904
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Marietta, Georgia, Estados Unidos, 30060
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Riverdale, Georgia, Estados Unidos, 30274
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
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Illinois
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Carbondale, Illinois, Estados Unidos, 62901
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Chicago, Illinois, Estados Unidos, 60625
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Geneva, Illinois, Estados Unidos, 60134
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Hoffman Estates, Illinois, Estados Unidos, 60169
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Joliet, Illinois, Estados Unidos, 60435
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Oak Lawn, Illinois, Estados Unidos, 60453
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Peoria, Illinois, Estados Unidos, 61614
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Rock Island, Illinois, Estados Unidos, 61201
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Rockford, Illinois, Estados Unidos, 61107
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Urbana, Illinois, Estados Unidos, 61801
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Indiana
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Elkhart, Indiana, Estados Unidos, 46514
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Ft Wayne, Indiana, Estados Unidos, 46805
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Hammond, Indiana, Estados Unidos, 46320
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Indianapolis, Indiana, Estados Unidos, 46250
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Lafayette, Indiana, Estados Unidos, 47905
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Muncie, Indiana, Estados Unidos, 47303
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Iowa
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Davenport, Iowa, Estados Unidos, 52803
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
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Overland Park, Kansas, Estados Unidos, 66209
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Topeka, Kansas, Estados Unidos, 66604
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Wichita, Kansas, Estados Unidos, 67220
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Kentucky
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Crestview Hills, Kentucky, Estados Unidos, 41017
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Lexington, Kentucky, Estados Unidos, 40504
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Owensboro, Kentucky, Estados Unidos, 42303
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Louisiana
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Alexandria, Louisiana, Estados Unidos, 71301
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Maine
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Lewiston, Maine, Estados Unidos, 04240
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Maryland
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Annapolis, Maryland, Estados Unidos, 21401
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Baltimore, Maryland, Estados Unidos, 21215
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Cumberland, Maryland, Estados Unidos, 21502
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Hagerstown, Maryland, Estados Unidos, 21740
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Salisbury, Maryland, Estados Unidos, 21804
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Takoma Park, Maryland, Estados Unidos, 20912
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01606
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
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Bay City, Michigan, Estados Unidos, 48708
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Dearborn, Michigan, Estados Unidos, 48124
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Detroit, Michigan, Estados Unidos, 48202
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Flint, Michigan, Estados Unidos, 48532
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Grand Blanc, Michigan, Estados Unidos, 48439
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Marquette, Michigan, Estados Unidos, 49855
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Mount Clemens, Michigan, Estados Unidos, 48043
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Saginaw, Michigan, Estados Unidos, 48602
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Southfield, Michigan, Estados Unidos, 48075
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St. Joseph, Michigan, Estados Unidos, 49085
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Troy, Michigan, Estados Unidos, 48085
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Warren, Michigan, Estados Unidos, 48093
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Wyoming, Michigan, Estados Unidos, 49519
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Minnesota
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Coon Rapids, Minnesota, Estados Unidos, 55433
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Duluth, Minnesota, Estados Unidos, 55805
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Edina, Minnesota, Estados Unidos, 55435
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Minneapolis, Minnesota, Estados Unidos, 55455
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St Cloud, Minnesota, Estados Unidos, 56303
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Missouri
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Columbia, Missouri, Estados Unidos, 65212
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Joplin, Missouri, Estados Unidos, 64804
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Kansas City, Missouri, Estados Unidos, 64114
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North Kansas City, Missouri, Estados Unidos, 64116
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Springfield, Missouri, Estados Unidos, 65804
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St Louis, Missouri, Estados Unidos, 63141
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Montana
-
Bozeman, Montana, Estados Unidos, 59715
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Kalispell, Montana, Estados Unidos, 59901
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Nebraska
-
Omaha, Nebraska, Estados Unidos, 68198
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Nevada
-
Las Vegas, Nevada, Estados Unidos, 89102
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Reno, Nevada, Estados Unidos, 89503
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New Hampshire
-
Nashua, New Hampshire, Estados Unidos, 03060
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New Jersey
-
Bridgewater, New Jersey, Estados Unidos, 08807
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Cherry Hill, New Jersey, Estados Unidos, 08034
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New Brunswick, New Jersey, Estados Unidos, 08901
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Newark, New Jersey, Estados Unidos, 07055
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Ridgewood, New Jersey, Estados Unidos, 07450
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Summit, New Jersey, Estados Unidos, 07902
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New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87131
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New York
-
Brooklyn, New York, Estados Unidos, 11215
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Elmira, New York, Estados Unidos, 14905
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Johnson City, New York, Estados Unidos, 13790
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New York, New York, Estados Unidos, 10075
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stony Brook, New York, Estados Unidos, 11794
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Utica, New York, Estados Unidos, 13501
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Valhalla, New York, Estados Unidos, 10595
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North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599
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Lumberton, North Carolina, Estados Unidos, 28358
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-
Raleigh, North Carolina, Estados Unidos, 27609
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-
Wilmington, North Carolina, Estados Unidos, 28402
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-
Winston-Salem, North Carolina, Estados Unidos, 27157
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
-
Canton, Ohio, Estados Unidos, 44710
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Cincinnati, Ohio, Estados Unidos, 45267
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kettering, Ohio, Estados Unidos, 45429
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-
Middleburg Heights, Ohio, Estados Unidos, 44130
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Toledo, Ohio, Estados Unidos, 43615
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Youngstown, Ohio, Estados Unidos, 44501
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Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73112
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Oregon
-
Bend, Oregon, Estados Unidos, 97701
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-
Portland, Oregon, Estados Unidos, 97225
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tualatin, Oregon, Estados Unidos, 97062
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
-
Abington, Pennsylvania, Estados Unidos, 19001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Allentown, Pennsylvania, Estados Unidos, 18104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bryn Mawr, Pennsylvania, Estados Unidos, 19010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Camp Hill, Pennsylvania, Estados Unidos, 17011
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Danville, Pennsylvania, Estados Unidos, 17822
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Darby, Pennsylvania, Estados Unidos, 19023
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Greensburg, Pennsylvania, Estados Unidos, 15601
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Harrisburg, Pennsylvania, Estados Unidos, 17111
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Hershey, Pennsylvania, Estados Unidos, 17033
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Johnstown, Pennsylvania, Estados Unidos, 15905
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Lancaster, Pennsylvania, Estados Unidos, 17602
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Langhorne, Pennsylvania, Estados Unidos, 19047
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Philadelphia, Pennsylvania, Estados Unidos, 19140
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
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Sayre, Pennsylvania, Estados Unidos, 18840
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Uniontown, Pennsylvania, Estados Unidos, 15401
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-
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South Carolina
-
Anderson, South Carolina, Estados Unidos, 29621
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-
Charleston, South Carolina, Estados Unidos, 29485
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-
Columbia, South Carolina, Estados Unidos, 29203
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-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38120
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-
Nashville, Tennessee, Estados Unidos, 37205
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75216
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-
Decatur, Texas, Estados Unidos, 76234
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-
Grapevine, Texas, Estados Unidos, 76051
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-
Houston, Texas, Estados Unidos, 77030
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-
Round Rock, Texas, Estados Unidos, 78665
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-
Temple, Texas, Estados Unidos, 76508
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-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
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-
Chesapeake, Virginia, Estados Unidos, 23320
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Danville, Virginia, Estados Unidos, 24541
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-
Newport News, Virginia, Estados Unidos, 23601
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-
Norfolk, Virginia, Estados Unidos, 23507
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-
Richmond, Virginia, Estados Unidos, 23320
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-
Roanoke, Virginia, Estados Unidos, 24018
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-
Virginia Beach, Virginia, Estados Unidos, 23454
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Winchester, Virginia, Estados Unidos, 22601
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Bellevue, Washington, Estados Unidos, 98004
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Everett, Washington, Estados Unidos, 98201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54308
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milwaukee, Wisconsin, Estados Unidos, 53215
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Racine, Wisconsin, Estados Unidos, 53405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Waukesha, Wisconsin, Estados Unidos, 53188
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rio Piedras, Puerto Rico, 00924
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Criterios de inclusión:
- mayor o igual a 18 años de edad
- diagnosticado con NSTEMI o STEMI tratado con una ICP durante la hospitalización índice
- iniciado (o continuado) en terapia con inhibidores del receptor de ADP antes del alta
- completamente informados y pueden dar su consentimiento por escrito para el seguimiento longitudinal y la recopilación de datos
Criterio de exclusión:
- participar simultáneamente en un estudio de investigación que dirige la elección de un inhibidor del receptor de ADP en investigación o aprobado dentro de los primeros 12 meses después del IM
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Tratamiento con inhibidores del receptor de ADP
Participantes ingresados por infarto de miocardio sin elevación del ST (NSTEMI) o infarto de miocardio con elevación del ST (STEMI) sometidos a intervención coronaria percutánea (ICP) y tratados con un inhibidor del receptor de ADP durante la hospitalización índice.
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Régimen de dosificación según lo determine el médico tratante.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Porcentaje de participantes con eventos cardiovasculares adversos mayores (MACE)
Periodo de tiempo: Línea de base hasta los 12 meses
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MACE se define como una combinación de muerte por todas las causas, infarto de miocardio (IM), accidente cerebrovascular o revascularización coronaria no planificada.
Los eventos que ocurrieron más de 7 días después de que se cambió o suspendió la medicación se excluyeron del análisis.
Se presentan los porcentajes observados (no ajustados) de participantes con MACE, así como los análisis estadísticos ajustados para las diferencias de cohortes iniciales.
Porcentaje de participantes = (número de participantes con eventos en 12 meses/número de participantes tratados) * 100.
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Línea de base hasta los 12 meses
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Factores asociados con la selección inicial del inhibidor del receptor de adenosina difosfato (ADP) en el momento de la inscripción
Periodo de tiempo: Día 0 (inscripción al estudio)
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Los factores son colocación de stent liberador de fármaco (DES) frente a stent de metal desnudo (BMS), otro (sin stent) frente a BMS, STEMI, otra raza, shock cardiogénico ocurrido dentro de las 24 horas, masculino, Cuestionario Europeo de Calidad de Vida-5 Dimensión Puntuación del estado de salud (EQ-5D): Estados Unidos (EE. UU.) Índice = 1 frente a < 1, casado, diabético y otros frente a colocación en BMS.
El índice EQ-5D US es un instrumento de calidad de vida relacionado con la salud y calificado por los participantes basado en la población estadounidense.
Las puntuaciones van desde -0,11 a 1,0 con 1,0 = salud perfecta.
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Día 0 (inscripción al estudio)
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Factores asociados con la selección inicial del inhibidor del receptor de ADP en el momento de la inscripción: Hemoglobina previa al procedimiento
Periodo de tiempo: Día 0 (inscripción al estudio)
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Día 0 (inscripción al estudio)
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Factores asociados con la selección inicial del inhibidor del receptor de ADP en el momento de la inscripción: índice de enfermedad arterial coronaria (CAD) de Duke
Periodo de tiempo: Día 0 (inscripción al estudio)
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El índice Duke CAD es una medida compuesta validada de la carga angiográfica, que asigna pesos pronósticos del 1 al 100.
Las puntuaciones más altas indican una mayor carga angiográfica y se asocian con un peor pronóstico.
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Día 0 (inscripción al estudio)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Porcentaje de participantes con eventos hemorrágicos acumulados severos o moderados
Periodo de tiempo: Línea base, 1, 6, 12 y 15 meses
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Los eventos de sangrado se recopilaron utilizando la definición de sangrado de la Utilización global de estreptoquinasa y activador de plasminógeno tisular para arterias coronarias ocluidas (GUSTO).
El sangrado GUSTO grave o potencialmente mortal no relacionado con el injerto de derivación de arteria coronaria (CABG) es cualquier hemorragia intracraneal (HIC) O cualquier evento de sangrado que resulte en un compromiso hemodinámico sustancial que requiera tratamiento.
El sangrado moderado GUSTO no relacionado con CABG es cualquier evento hemorrágico que resulta en la necesidad de una transfusión que no se considera un sangrado grave o potencialmente mortal según GUSTO.
Los eventos hemorrágicos adicionales son hemorragia fatal o HIC, o cualquier evento hemorrágico no fatal relacionado con la cirugía que lleve a ≥4 unidades de transfusión de glóbulos rojos.
Se presentan los porcentajes observados (no ajustados) de participantes con eventos hemorrágicos, así como los análisis estadísticos ajustados para las diferencias de cohortes iniciales.
Porcentaje de participantes = (número de participantes con eventos / número de participantes tratados) * 100.
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Línea base, 1, 6, 12 y 15 meses
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Porcentaje de participantes con MACE y que no tenían antecedentes de ataque isquémico transitorio (AIT)/accidente cerebrovascular, peso ≥60 kilogramos (kg) y edad <75 años
Periodo de tiempo: Línea de base hasta los 12 meses
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MACE se define como una combinación de muerte por todas las causas, infarto de miocardio, accidente cerebrovascular o revascularización coronaria no planificada.
Los eventos que ocurrieron más de 7 días después de que se cambió o suspendió la medicación se excluyeron del análisis.
Se presentan los porcentajes observados (no ajustados) de participantes con MACE, así como los análisis estadísticos ajustados para las diferencias de cohortes iniciales.
Porcentaje de participante = (número de participantes con eventos / número de participantes tratados) * 100.
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Línea de base hasta los 12 meses
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Porcentaje de participantes con MACE durante 1, 6 y 15 meses
Periodo de tiempo: Línea base a 1, 6 y 15 meses
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MACE se define como una combinación de muerte por todas las causas, infarto de miocardio, accidente cerebrovascular o revascularización coronaria no planificada.
Los eventos que ocurrieron más de 7 días después de que se cambió o suspendió la medicación se excluyeron del análisis.
Se presentan los porcentajes observados (no ajustados) de participantes con MACE.
Se utilizó el análisis de Kaplan-Meier para estimar el porcentaje de participantes con un evento MACE.
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Línea base a 1, 6 y 15 meses
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Porcentaje de participantes con eventos de trombosis del stent (ST) definitivos o probables
Periodo de tiempo: Línea de base hasta los 15 meses
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Se utilizaron los criterios del Consorcio de Investigación Académica (ARC) para definir ST.
ST definitiva es la confirmación angiográfica o patológica de oclusión trombótica parcial o total dentro de la región peri-stent, y al menos 1 de los siguientes criterios adicionales: síntomas isquémicos agudos; cambios electrocardiográficos isquémicos; biomarcadores cardíacos elevados.
Probable ST es cualquier muerte inexplicable dentro de los 30 días posteriores a la implantación del stent; cualquier IM, que esté relacionado con isquemia aguda documentada en el territorio del stent implantado sin confirmación angiográfica de ST y en ausencia de cualquier otra causa obvia.
Los eventos que ocurrieron más de 7 días después de que se cambió o suspendió la medicación se excluyeron del análisis.
Se presentan los porcentajes observados (no ajustados) de participantes con eventos ST.
Se utilizó el análisis de Kaplan-Meier para estimar el porcentaje de participantes con un evento de ST definitivo o probable.
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Línea de base hasta los 15 meses
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Patrones de uso de recursos, costos médicos totales acumulados y rentabilidad
Periodo de tiempo: 15 meses
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15 meses
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST), Eli Lilly and Company
Publicaciones y enlaces útiles
Publicaciones Generales
- Rymer JA, Kaltenbach LA, Doll JA, Messenger JC, Peterson ED, Wang TY. Safety of Dual-Antiplatelet Therapy After Myocardial Infarction Among Patients With Chronic Kidney Disease. J Am Heart Assoc. 2019 May 21;8(10):e012236. doi: 10.1161/JAHA.119.012236.
- Warraich HJ, Kaltenbach LA, Fonarow GC, Peterson ED, Wang TY. Adverse Change in Employment Status After Acute Myocardial Infarction: Analysis From the TRANSLATE-ACS Study. Circ Cardiovasc Qual Outcomes. 2018 Jun;11(6):e004528. doi: 10.1161/CIRCOUTCOMES.117.004528.
- Fanaroff AC, Kaltenbach LA, Peterson ED, Akhter MW, Effron MB, Henry TD, Wang TY. Antiplatelet Therapy Changes for Patients With Myocardial Infarction With Recurrent Ischemic Events: Insights Into Contemporary Practice From the TRANSLATE-ACS (Treatment With ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome) Study. J Am Heart Assoc. 2018 Feb 8;7(4):e007982. doi: 10.1161/JAHA.117.007982.
- Tisminetzky M, Wang TY, Gurwitz J, Kaltenbach LA, McManus D, Gore J, Peterson E, Goldberg RJ. Magnitude and Characteristics of Patients Who Survived an Acute Myocardial Infarction. J Am Heart Assoc. 2017 Sep 25;6(9):e006373. doi: 10.1161/JAHA.117.006373.
- Guimaraes PO, Krishnamoorthy A, Kaltenbach LA, Anstrom KJ, Effron MB, Mark DB, McCollam PL, Davidson-Ray L, Peterson ED, Wang TY. Accuracy of Medical Claims for Identifying Cardiovascular and Bleeding Events After Myocardial Infarction : A Secondary Analysis of the TRANSLATE-ACS Study. JAMA Cardiol. 2017 Jul 1;2(7):750-757. doi: 10.1001/jamacardio.2017.1460.
- Hess CN, Kaltenbach LA, Doll JA, Cohen DJ, Peterson ED, Wang TY. Race and Sex Differences in Post-Myocardial Infarction Angina Frequency and Risk of 1-Year Unplanned Rehospitalization. Circulation. 2017 Feb 7;135(6):532-543. doi: 10.1161/CIRCULATIONAHA.116.024406.
- Jackson LR 2nd, Peterson ED, McCoy LA, Ju C, Zettler M, Baker BA, Messenger JC, Faries DE, Effron MB, Cohen DJ, Wang TY. Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. J Am Heart Assoc. 2016 Oct 21;5(10):e003824. doi: 10.1161/JAHA.116.003824.
- Fosbol EL, Ju C, Anstrom KJ, Zettler ME, Messenger JC, Waksman R, Effron MB, Baker BA, Cohen DJ, Peterson ED, Wang TY. Early Cessation of Adenosine Diphosphate Receptor Inhibitors Among Acute Myocardial Infarction Patients Treated With Percutaneous Coronary Intervention: Insights From the TRANSLATE-ACS Study (Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome). Circ Cardiovasc Interv. 2016 Nov;9(11):e003602. doi: 10.1161/CIRCINTERVENTIONS.115.003602.
- Krishnamoorthy A, Peterson ED, Knight JD, Anstrom KJ, Effron MB, Zettler ME, Davidson-Ray L, Baker BA, McCollam PL, Mark DB, Wang TY. How Reliable are Patient-Reported Rehospitalizations? Implications for the Design of Future Practical Clinical Studies. J Am Heart Assoc. 2016 Jan 25;5(1):e002695. doi: 10.1161/JAHA.115.002695.
- Hess CN, Wang TY, McCoy LA, Messenger JC, Effron MB, Zettler ME, Henry TD, Peterson ED, Fonarow GC. Unplanned Inpatient and Observation Rehospitalizations After Acute Myocardial Infarction: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circulation. 2016 Feb 2;133(5):493-501. doi: 10.1161/CIRCULATIONAHA.115.017001. Epub 2015 Dec 17.
- Wang TY, Henry TD, McCoy LA, Berger PB, Cohen DJ, Effron MB, Zettler M, Baker BA, Messenger JC, Peterson ED. Contemporary use of platelet function and pharmacogenomic testing among patients with acute myocardial infarction undergoing percutaneous coronary intervention in the United States. Am Heart J. 2015 Oct;170(4):706-14. doi: 10.1016/j.ahj.2015.06.021. Epub 2015 Jul 2.
- Mathews R, Wang TY, Honeycutt E, Henry TD, Zettler M, Chang M, Fonarow GC, Peterson ED; TRANSLATE-ACS Study Investigators. Persistence with secondary prevention medications after acute myocardial infarction: Insights from the TRANSLATE-ACS study. Am Heart J. 2015 Jul;170(1):62-9. doi: 10.1016/j.ahj.2015.03.019. Epub 2015 Apr 2.
- Mathews R, Peterson ED, Honeycutt E, Chin CT, Effron MB, Zettler M, Fonarow GC, Henry TD, Wang TY. Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):347-56. doi: 10.1161/CIRCOUTCOMES.114.001223. Epub 2015 Jun 2.
- Wang TY, Henry TD, Effron MB, Honeycutt E, Hess CN, Zettler ME, Cohen DJ, Baker BA, Berger PB, Anstrom KJ, Angiolillo DJ, Peterson ED; TRANSLATE-POPS Investigators. Cluster-randomized clinical trial examining the impact of platelet function testing on practice: the treatment with adenosine diphosphate receptor inhibitors: longitudinal assessment of treatment patterns and events after acute coronary syndrome prospective open label antiplatelet therapy study. Circ Cardiovasc Interv. 2015 Jun;8(6):e001712. doi: 10.1161/CIRCINTERVENTIONS.114.001712.
- Xian Y, Wang TY, McCoy LA, Effron MB, Henry TD, Bach RG, Zettler ME, Baker BA, Fonarow GC, Peterson ED. Association of Discharge Aspirin Dose With Outcomes After Acute Myocardial Infarction: Insights From the Treatment with ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circulation. 2015 Jul 21;132(3):174-81. doi: 10.1161/CIRCULATIONAHA.114.014992. Epub 2015 May 20.
- Bagai A, Peterson ED, Honeycutt E, Effron MB, Cohen DJ, Goodman SG, Anstrom KJ, Gupta A, Messenger JC, Wang TY. In-hospital switching between adenosine diphosphate receptor inhibitors in patients with acute myocardial infarction treated with percutaneous coronary intervention: Insights into contemporary practice from the TRANSLATE-ACS study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):499-508. doi: 10.1177/2048872614564082. Epub 2014 Dec 16.
- Hess CN, McCoy LA, Duggirala HJ, Tavris DR, O'Callaghan K, Douglas PS, Peterson ED, Wang TY. Sex-based differences in outcomes after percutaneous coronary intervention for acute myocardial infarction: a report from TRANSLATE-ACS. J Am Heart Assoc. 2014 Feb 7;3(1):e000523. doi: 10.1161/JAHA.113.000523.
- Wang TY, McCoy L, Henry TD, Effron MB, Messenger JC, Cohen DJ, Mark DB, Stone GW, Zettler M, Singh M, Fonarow GC, Peterson ED; TRANSLATE-ACS Study Investigators. Early post-discharge bleeding and antiplatelet therapy discontinuation among acute myocardial infarction patients treated with percutaneous coronary intervention. J Am Coll Cardiol. 2014 Apr 29;63(16):1700-2. doi: 10.1016/j.jacc.2013.12.012. Epub 2014 Jan 30. No abstract available.
- Chin CT, Wang TY, Anstrom KJ, Zhu B, Maa JF, Messenger JC, Ryan KA, Davidson-Ray L, Zettler M, Effron MB, Mark DB, Peterson ED. Treatment with adenosine diphosphate receptor inhibitors-longitudinal assessment of treatment patterns and events after acute coronary syndrome (TRANSLATE-ACS) study design: expanding the paradigm of longitudinal observational research. Am Heart J. 2011 Nov;162(5):844-51. doi: 10.1016/j.ahj.2011.08.021.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12549
- H7T-US-B007 (Otro identificador: Eli Lilly and Company)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Inhibidores de los receptores de ADP
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