- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01088503
Tratamento com inibidores do receptor de difosfato de adenosina (ADP): avaliação longitudinal dos padrões de tratamento e eventos após a síndrome coronariana aguda (TRANSLATE-ACS)
O estudo TRANSLATE-ACS: tratamento com inibidores do receptor de ADP: avaliação longitudinal dos padrões de tratamento e eventos após a síndrome coronariana aguda
O estudo TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) é um estudo prospectivo e observacional longitudinal para avaliar a eficácia do mundo real e o uso de prasugrel e outras terapias com inibidores de ADP no infarto do miocárdio (MI) participantes tratados com intervenção coronária percutânea (ICP) durante a hospitalização índice. O gerenciamento do participante e as decisões de tratamento ficam a critério da equipe de atendimento de acordo com a prática clínica de rotina. Aproximadamente 17.000 participantes serão inscritos em aproximadamente 350 locais nos Estados Unidos. O acompanhamento será realizado por 15 meses em aproximadamente 15.650 participantes.
O TRANSLATE-ACS complementará os resultados de ensaios clínicos controlados randomizados e registros atuais ao abordar os padrões de tratamento do mundo real e os resultados clínicos para participantes com infarto do miocárdio tratados com ICP e iniciados em terapia com inibidor de receptor de ADP. Além de determinar a eficácia do prasugrel em comparação com outros inibidores do receptor ADP, o estudo também determinará fatores associados à seleção inicial do inibidor do receptor ADP e padrões longitudinais de uso, avaliará a segurança e descreverá e comparará o uso de recursos e custos médicos associados com Inibidores do receptor de ADP. Além disso, este estudo irá gerar um continuum de informações do paciente internado para o ambulatório para fornecer uma imagem abrangente do tratamento do participante e dos resultados não disponíveis atualmente para os novos inibidores do receptor de ADP.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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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
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Nashua, New Hampshire, Estados Unidos, 03060
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New Jersey
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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
- 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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New York
-
Brooklyn, New York, Estados Unidos, 11215
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Elmira, New York, Estados Unidos, 14905
- 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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Johnson City, New York, Estados Unidos, 13790
- 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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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
- 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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Utica, New York, Estados Unidos, 13501
- 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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Valhalla, New York, Estados Unidos, 10595
- 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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North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- 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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Lumberton, North Carolina, Estados Unidos, 28358
- 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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Raleigh, North Carolina, Estados Unidos, 27609
- 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.
-
Wilmington, North Carolina, Estados Unidos, 28402
- 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.
-
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
- 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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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
- 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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Middleburg Heights, Ohio, Estados Unidos, 44130
- 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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Toledo, Ohio, Estados Unidos, 43615
- 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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Youngstown, Ohio, Estados Unidos, 44501
- 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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Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73112
- 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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Oregon
-
Bend, Oregon, Estados Unidos, 97701
- 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.
-
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.
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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
- 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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Darby, Pennsylvania, Estados Unidos, 19023
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Greensburg, Pennsylvania, Estados Unidos, 15601
- 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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Harrisburg, Pennsylvania, Estados Unidos, 17111
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Hershey, Pennsylvania, Estados Unidos, 17033
- 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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Johnstown, Pennsylvania, Estados Unidos, 15905
- 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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Lancaster, Pennsylvania, Estados Unidos, 17602
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Langhorne, Pennsylvania, Estados Unidos, 19047
- 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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Philadelphia, Pennsylvania, Estados Unidos, 19140
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
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Sayre, Pennsylvania, Estados Unidos, 18840
- 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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Uniontown, Pennsylvania, Estados Unidos, 15401
- 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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South Carolina
-
Anderson, South Carolina, Estados Unidos, 29621
- 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.
-
Charleston, South Carolina, Estados Unidos, 29485
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-
Columbia, South Carolina, Estados Unidos, 29203
- 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.
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38120
- 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.
-
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
- 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.
-
Decatur, Texas, Estados Unidos, 76234
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-
Grapevine, Texas, Estados Unidos, 76051
- 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.
-
Houston, Texas, Estados Unidos, 77030
- 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.
-
Round Rock, Texas, Estados Unidos, 78665
- 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.
-
Temple, Texas, Estados Unidos, 76508
- 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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Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
- 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.
-
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
- 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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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, Porto 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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Critério de inclusão:
- maior ou igual a 18 anos
- diagnosticado com NSTEMI ou STEMI tratado com ICP durante a hospitalização índice
- iniciado (ou continuado) em terapia com inibidor do receptor de ADP antes da alta
- totalmente informados e são capazes de fornecer consentimento por escrito para acompanhamento longitudinal e coleta de dados
Critério de exclusão:
- participando simultaneamente de um estudo de pesquisa que direciona a escolha de um inibidor do receptor de ADP em investigação ou aprovado nos primeiros 12 meses após o infarto do miocárdio
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Tratamento com inibidor do receptor de ADP
Participantes admitidos por infarto do miocárdio sem elevação do segmento ST (NSTEMI) ou infarto do miocárdio com elevação do segmento ST (STEMI) submetidos a intervenção coronária percutânea (ICP) e tratados com um inibidor do receptor de ADP durante a hospitalização índice.
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Regime de dosagem conforme determinado pelo médico assistente.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Porcentagem de participantes com eventos cardiovasculares adversos graves (MACE)
Prazo: Linha de base até 12 meses
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MACE é definido como um composto de morte por todas as causas, infarto do miocárdio (IM), acidente vascular cerebral ou revascularização coronária não planejada.
Eventos que ocorreram mais de 7 dias após a troca ou descontinuação da medicação foram excluídos da análise.
São apresentadas as porcentagens observadas (não ajustadas) de participantes com MACE, bem como as análises estatísticas ajustadas para diferenças de coorte de linha de base.
Porcentagem de participantes = (número de participantes com eventos em 12 meses/ número de participantes tratados) * 100.
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Linha de base até 12 meses
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Fatores associados à seleção inicial do inibidor do receptor de difosfato de adenosina (ADP) na inscrição
Prazo: Dia 0 (inscrição no estudo)
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Os fatores são stents farmacológicos (DES) vs. colocação de stents convencionais (BMS), outro (sem stent) vs. BMS, STEMI, outra raça, choque cardiogênico ocorrido em 24 horas, masculino, European Quality of Life Questionnaire-5 Dimension Pontuação do estado de saúde (EQ-5D) - Índice dos Estados Unidos (EUA) =1 vs. <1, casado, diabético e outro vs. colocação de BMS.
O índice EQ-5D US é um instrumento de qualidade de vida relacionado à saúde avaliado pelos participantes com base na população dos EUA.
As pontuações variam de -0,11 a 1,0 com 1,0 = saúde perfeita.
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Dia 0 (inscrição no estudo)
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Fatores Associados à Seleção Inicial do Inibidor do Receptor de ADP na Inscrição: Hemoglobina Pré-Procedimento
Prazo: Dia 0 (inscrição no estudo)
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Dia 0 (inscrição no estudo)
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Fatores Associados à Seleção Inicial do Inibidor do Receptor de ADP na Inscrição: Índice de Doença Arterial Coronariana (DAC) de Duke
Prazo: Dia 0 (inscrição no estudo)
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O Duke CAD Index é uma medida composta validada de carga angiográfica, que atribui pesos prognósticos de 1 a 100.
Pontuações mais altas indicam maior carga angiográfica e estão associadas a pior prognóstico.
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Dia 0 (inscrição no estudo)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Porcentagem de participantes com eventos de sangramento moderado ou grave cumulativo
Prazo: Linha de base, 1, 6, 12 e 15 meses
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Os eventos hemorrágicos foram coletados utilizando a definição de sangramento da utilização global de estreptoquinase e ativador de plasminogênio tecidual para artérias coronárias obstruídas (GUSTO).
O sangramento GUSTO grave ou com risco de vida não relacionado à cirurgia de revascularização do miocárdio (CABG) é qualquer hemorragia intracraniana (ICH) OU qualquer evento hemorrágico que resulte em comprometimento hemodinâmico substancial que requeira tratamento.
Sangramento moderado GUSTO não relacionado a CABG é qualquer evento hemorrágico resultando na necessidade de transfusão que não é considerado um sangramento GUSTO grave ou com risco de vida.
Eventos hemorrágicos adicionais são sangramentos fatais ou ICH, ou quaisquer eventos hemorrágicos não fatais relacionados à cirurgia que levem a ≥4 unidades de transfusão de hemácias.
São apresentadas as porcentagens observadas (não ajustadas) de participantes com eventos hemorrágicos, bem como as análises estatísticas ajustadas para diferenças de coorte de linha de base.
Porcentagem de participantes = (número de participantes com eventos / número de participantes tratados) * 100.
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Linha de base, 1, 6, 12 e 15 meses
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Porcentagem de participantes com MACE e que não tinham histórico prévio de ataque isquêmico transitório (AIT)/AVC, pesam ≥60 kg (kg) e têm idade <75 anos
Prazo: Linha de base até 12 meses
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MACE é definido como um composto de morte por todas as causas, infarto do miocárdio, acidente vascular cerebral ou revascularização coronária não planejada.
Eventos que ocorreram mais de 7 dias após a troca ou descontinuação da medicação foram excluídos da análise.
São apresentadas as porcentagens observadas (não ajustadas) de participantes com MACE, bem como as análises estatísticas ajustadas para diferenças de coorte de linha de base.
Porcentagem de participante = (número de participantes com eventos / número de participantes tratados) * 100.
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Linha de base até 12 meses
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Porcentagem de participantes com MACE em 1, 6 e 15 meses
Prazo: Linha de base até 1, 6 e 15 meses
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MACE é definido como um composto de morte por todas as causas, infarto do miocárdio, acidente vascular cerebral ou revascularização coronária não planejada.
Eventos que ocorreram mais de 7 dias após a troca ou descontinuação da medicação foram excluídos da análise.
As porcentagens observadas (não ajustadas) de participantes com MACE são apresentadas.
A análise de Kaplan-Meier foi usada para estimar a porcentagem de participantes com um evento MACE.
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Linha de base até 1, 6 e 15 meses
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Porcentagem de participantes com eventos de trombose de stent (ST) definida ou provável
Prazo: Linha de base até 15 meses
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Os critérios do Academic Research Consortium (ARC) foram usados para definir ST.
ST definitivo é a confirmação angiográfica ou patológica de oclusão trombótica parcial ou total na região peri-stent e pelo menos 1 dos seguintes critérios adicionais: sintomas isquêmicos agudos; alterações eletrocardiográficas isquêmicas; biomarcadores cardíacos elevados.
ST provável é qualquer morte inexplicável dentro de 30 dias após a implantação do stent; qualquer IM, que esteja relacionado com isquemia aguda documentada no território do stent implantado sem confirmação angiográfica de ST e na ausência de qualquer outra causa óbvia.
Eventos que ocorreram mais de 7 dias após a troca ou descontinuação da medicação foram excluídos da análise.
As porcentagens observadas (não ajustadas) de participantes com eventos ST são apresentadas.
A análise de Kaplan-Meier foi usada para estimar a porcentagem de participantes com um evento definitivo ou provável de ST.
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Linha de base até 15 meses
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Padrões de Uso de Recursos, Custos Médicos Totais Cumulativos e Efetividade de Custos
Prazo: 15 meses
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15 meses
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12549
- H7T-US-B007 (Outro identificador: Eli Lilly and Company)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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