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Una comparación de prasugrel en la ICP o en el momento del diagnóstico de infarto de miocardio sin elevación del segmento ST (ACCOAST)

17 de enero de 2014 actualizado por: Eli Lilly and Company

Una comparación de prasugrel en el momento de la intervención coronaria percutánea (PCI) o como pretratamiento en el momento del diagnóstico en pacientes con infarto de miocardio sin elevación del ST (NSTEMI): el estudio ACCOAST

El propósito de este ensayo es investigar los beneficios/riesgos potenciales con respecto al pretratamiento con prasugrel en participantes con infarto de miocardio sin elevación del ST (NSTEMI) con troponina elevada programados para angiografía coronaria/intervención coronaria percutánea (ICP).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Este ensayo consta de dos brazos. Un brazo es un brazo sin pretratamiento. Los participantes de este grupo recibirán placebo inmediatamente después del diagnóstico de NSTEMI y antes de la angiografía coronaria de diagnóstico. Se administrará una dosis de carga de 60 mg de prasugrel inmediatamente después de la angiografía coronaria cuando se proceda a la ICP. Posteriormente, los participantes recibirán dosis diarias de mantenimiento de prasugrel hasta el día 30. Los participantes mayores o iguales a 75 años de edad o que tengan un peso corporal inferior a 60 kilogramos (kg) recibirán una dosis oral de 5 mg al día. Todos los demás recibirán una dosis de mantenimiento oral diaria de 10 mg durante 30 días.

El otro brazo es un brazo de pretratamiento en el que los participantes recibirán un régimen de dosis de carga dividida con 30 mg de prasugrel administrados inmediatamente después del diagnóstico de NSTEMI y antes de la angiografía coronaria de diagnóstico. El resto de la dosis de carga (30 mg) se administrará cuando los participantes vayan a PCI. Posteriormente, los participantes recibirán dosis diarias de mantenimiento de prasugrel hasta el día 30. Los participantes mayores o iguales a 75 años o que tengan un peso corporal inferior a 60 kg recibirán una dosis oral de 5 mg al día. Todos los demás recibirán una dosis de mantenimiento oral diaria de 10 mg durante 30 días.

Tipo de estudio

Intervencionista

Inscripción (Actual)

4033

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Nauheim, Alemania, 61231
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      • Bad Segeberg, Alemania, 23795
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      • Bochum, Alemania, 44791
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      • Bonn, Alemania, 53105
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      • Coburg, Alemania, 96450
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      • Dachau, Alemania, 85221
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      • Eutin, Alemania, 23701
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      • Frankfurt, Alemania, 60596
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      • Halle, Alemania, 06120
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      • Hamburg, Alemania, 20099
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      • Hannover, Alemania, 30625
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      • Heidelberg, Alemania, D-69120
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      • Jena, Alemania, 07740
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      • Kassel, Alemania, 34125
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      • Leipzig, Alemania, 04289
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      • Ludwigshafen, Alemania, 67063
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      • Mainz, Alemania, 55101
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      • Munich, Alemania, 80336
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      • Rastatt, Alemania, 76437
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      • Rostock, Alemania, 18057
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      • Villingen-Schwenningen, Alemania, 78050
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  • Austria
      • Braunau Am Inn, Austria, 5280
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      • Graz, Austria, 8020
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      • Linz, Austria, 4020
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      • Vienna, Austria, A1090
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  • Bélgica
      • Bonheiden, Bélgica, 2820
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      • Brugge, Bélgica, 8000
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      • Charleroi, Bélgica, 6000
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      • Genk, Bélgica, 3600
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      • Leuven, Bélgica, 3000
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      • Yvoir, Bélgica, 5530
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  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 2T9
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    • British Columbia
      • Vancouver, British Columbia, Canadá, Vancouver
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    • Ontario
      • Toronto, Ontario, Canadá, M5B 1W8
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    • Quebec
      • Montreal, Quebec, Canadá, H4J 1C5
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      • Sainte-Foy, Quebec, Canadá, G1V 4G5
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    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá, S7N 0W8
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  • Eslovaquia
      • Banska Bystrica, Eslovaquia, 97401
        • 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.
      • Kosice, Eslovaquia, 04011
        • 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.
      • Nitra, Eslovaquia, 94901
        • 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.
  • Finlandia
      • Turku, Finlandia, 20521
        • 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.
  • Francia
      • Bastia, Francia, 20600
        • 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.
      • Bron, Francia, 69500
        • 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.
      • Caluire Et Cuire, Francia, 69300
        • 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.
      • Cannes Cedex, Francia, 06401
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      • Chateauroux, Francia, 36019
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      • Corbeil Essonnes, Francia, 91106
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      • Lagny Sur Marne, Francia, 77405
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      • Le Coudray, Francia, 28630
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      • Lille, Francia, 59037
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      • Lyon, Francia, 69317
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      • Marseille, Francia, 13015
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      • Metz, Francia, 57085
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      • Metz Tessy, Francia, 74370
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      • Montauban, Francia, 82017
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      • Montreuil, Francia, 93105
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      • Nimes, Francia, 30029
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      • Paris, Francia, 75743
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      • Pau Cedex, Francia, 64046
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      • Pierre Benite, Francia, 69495
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      • Rennes, Francia, 35033
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      • Toulouse, Francia, 31076
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      • Valence, Francia, 26953
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      • Vannes, Francia, 56017
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      • Vienne, Francia, 38209
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      • Villeurbanne, Francia, 69100
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  • Hungría
      • Balatonfured, Hungría, 8230
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      • Budapest, Hungría, 1096
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      • Pecs, Hungría, 7624
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      • Zalaegerszeg, Hungría, 8900
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  • Israel
      • Beer Yaakov, Israel, 70300
        • 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.
      • Haifa, Israel, 34362
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      • Jerusalem, Israel, 91120
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      • Kfar Saba, Israel, 44281
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      • Nahariya, Israel, 22100
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      • Tel-Aviv, Israel, 64239
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      • Tiberias, Israel, 15208
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  • Italia
      • Arezzo, Italia, 52100
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      • Chieti, Italia, 66013
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      • Grosseto, Italia, 58100
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      • Legnano, Italia, 20025
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      • Lucca, Italia
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      • Massa, Italia, 54100
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      • Monza, Italia, 20900
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      • Napoli, Italia, 80100
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      • Pavia, Italia, 27100
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      • Perugia, Italia, 06156
        • 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.
      • Pisa, Italia, 56100
        • 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.
      • Prato, Italia, 50047
        • 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.
      • Reggio Emilia, Italia, 42100
        • 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.
      • Rome, Italia, 00100
        • 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.
      • Torino, Italia, 10100
        • 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.
      • Udine, Italia, 33100
        • 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.
      • Venezia, Italia, 30035
        • 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.
  • Letonia
      • Liepaja, Letonia, 3414
        • 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.
      • Riga, Letonia, 1038
        • 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.
  • Lituania
      • Kaunas, Lituania, LT-50009
        • 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.
      • Klaipedos, Lituania, 92288
        • 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.
      • Vilnius, Lituania, LT-08661
        • 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.
  • Pavo
      • Adana, Pavo, 1330
        • 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.
      • Ankara, Pavo, 06520
        • 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.
      • Antalya, Pavo, 07070
        • 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.
      • Fatih, Pavo, 34300
        • 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.
      • Isparta, Pavo, 32100
        • 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.
      • Istanbul, Pavo, 34303
        • 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.
      • Kayseri, Pavo, 38039
        • 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.
      • Kocaeli, Pavo, 41900
        • 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.
      • Sisli, Pavo, 34381
        • 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.
  • Países Bajos
      • Amsterdam, Países Bajos, 1081 HV
        • 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.
      • Eindhoven, Países Bajos, 5623 EJ
        • 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.
      • Leeuwarden, Países Bajos, 8934 AD
        • 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.
      • Nieuwegein, Países Bajos, 3435 CM
        • 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.
      • Nijmegen, Países Bajos, 6500 HB
        • 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.
      • Tiel, Países Bajos, 4002 WP
        • 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.
      • Zwolle, Países Bajos, 8025 AB
        • 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.
  • Polonia
      • Belchatow, Polonia, 97-400
        • 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.
      • Chrzanow, Polonia, 32-500
        • 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.
      • Grodzisk Mazowiecki, Polonia, 05-825
        • 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.
      • Katowice, Polonia, 40-635
        • 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.
      • Klodzko, Polonia, 57-300
        • 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.
      • Krakow, Polonia, 31-501
        • 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.
      • Lodz, Polonia, 91-347
        • 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.
      • Lublin, Polonia, 20-954
        • 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.
      • Mielec, Polonia, 39-300
        • 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.
      • Naleczow, Polonia, 24-140
        • 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.
      • Nowy Sacz, Polonia, 33-300
        • 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.
      • Nowy Targ, Polonia, 34-400
        • 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.
      • Nysa, Polonia, 48-300
        • 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.
      • Ostrowiec Swietokrzyski, Polonia, 27-400
        • 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.
      • Oswiecim, Polonia, 32-600
        • 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.
      • Polanica-Zdroj, Polonia, 57-320
        • 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.
      • Pulawy, Polonia, 24-100
        • 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.
      • Radom, Polonia, 26-617
        • 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.
      • Sanok, Polonia, 38-500
        • 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.
      • Stalowa Wola, Polonia, 37-450
        • 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.
      • Starogard Gdanski, Polonia, 82-200
        • 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.
      • Tarnow, Polonia, 33-100
        • 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.
      • Warsaw, Polonia, 04-628
        • 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.
      • Wejherowo, Polonia, 84-200
        • 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.
      • Wroclaw, Polonia, 53-114
        • 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.
  • Portugal
      • Braga, Portugal, 4710-243
        • 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.
      • Carnaxide, Portugal, 2794-006
        • 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.
      • Faro, Portugal, 8000-386
        • 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.
      • Leiria, Portugal, 2410-197
        • 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.
  • República Checa
      • Brno, República Checa, 625 00
        • 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.
      • Hradec Kralove, República Checa, 500 05
        • 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.
      • Olomouc, República Checa, 775 20
        • 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.
      • Plzen, República Checa, 30460
        • 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.
      • Prague, República Checa, 169 02
        • 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.
      • Usti Nad Labem, República Checa, 40113
        • 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.
  • Rumania
      • Bucharest, Rumania, 050098
        • 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.
      • Targu Mures, Rumania, 540136
        • 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.
  • Suecia
      • Goteborg, Suecia, 413 45
        • 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.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Criterios de inclusión:

  • Tiene un síndrome coronario agudo que consiste en una elevación del segmento ST sin elevación de la troponina
  • Programado para angiografía coronaria/PCI mayor o igual a 2 y menos de 24 horas desde el momento de la aleatorización planificada, pero no más de 48 horas desde la aleatorización
  • Debe ser elegible para el tratamiento con prasugrel, aspirina (ASA) y un inhibidor del receptor de glicoproteína IIb/IIIa (GPIIb/IIIa) según las etiquetas respectivas
  • Puede estar en una dosis de mantenimiento de clopidogrel de 75 mg y debe poder cambiar a prasugrel
  • Debe estar inscrito en un hospital con laboratorio de cateterismo cardíaco o en un hospital/servicio de ambulancia afiliado a un hospital con laboratorio de cateterismo cardíaco

Criterio de exclusión:

  • Presentar infarto de miocardio con elevación del segmento ST (IAMCEST) en el momento del ingreso o la aleatorización
  • Tiene shock cardiogénico
  • Tiene arritmias ventriculares refractarias
  • Tiene insuficiencia cardíaca congestiva (CHF) de clase IV de la New York Heart Association (NYHA)
  • Haber tenido un paro cardíaco dentro de 1 semana de la entrada o aleatorización en el estudio

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Sin pretratamiento
Se administra una dosis de carga oral de placebo en el momento del diagnóstico y una dosis de carga oral de 60 miligramos (mg) de prasugrel en el momento de la ICP seguida de una dosis de mantenimiento oral diaria de 5 mg o 10 mg de prasugrel durante 30 días.
Droga: Prasugrel
Administrado por vía oral
Otros nombres:
  • Eficiente
  • LY640315
  • CS-747
Droga: Placebo
Administrado una vez por vía oral
Experimental: Dosis de carga dividida
Se administra una dosis oral de carga de 30 mg de prasugrel en el momento del diagnóstico y una dosis oral de 30 mg de prasugrel en el momento de la ICP, seguida de una dosis de mantenimiento diaria oral de 5 mg o 10 mg de prasugrel durante 30 días.
Droga: Prasugrel
Administrado por vía oral
Otros nombres:
  • Eficiente
  • LY640315
  • CS-747

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
El porcentaje de participantes con muerte cardiovascular (CV), infarto de miocardio (IM), accidente cerebrovascular, revascularización urgente (UR) o rescate del inhibidor de la glicoproteína (GP) IIb/IIIa
Periodo de tiempo: Primera dosis de carga (LD) hasta 7 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte CV, infarto de miocardio, accidente cerebrovascular, UR o rescate con inhibidor de GPIIb/IIIa dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera dosis de carga (LD) hasta 7 días después de la primera LD

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Porcentaje de participantes con muerte por todas las causas, infarto de miocardio (IM), accidente cerebrovascular o injerto de derivación de toda la arteria coronaria (CABG) y trombolisis no CABG en el infarto de miocardio (TIMI) Sangrado mayor
Periodo de tiempo: Primera dosis de carga (LD) hasta 7 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte por todas las causas, infarto de miocardio, accidente cerebrovascular o CABG y sangrado mayor TIMI no CABG dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera dosis de carga (LD) hasta 7 días después de la primera LD
Porcentaje de participantes con incidencia de muerte cardiovascular (CV), infarto de miocardio (IM) o accidente cerebrovascular durante los 30 días posteriores a la primera dosis de carga (LD)
Periodo de tiempo: Primera LD hasta 30 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte CV, un IM o un accidente cerebrovascular dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera LD hasta 30 días después de la primera LD
Porcentaje de participantes con incidencia de muerte cardiovascular (CV) o infarto de miocardio (IM) durante 30 días desde la primera dosis de carga (LD)
Periodo de tiempo: Primera LD hasta 30 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte CV o un IM dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera LD hasta 30 días después de la primera LD
Porcentaje de participantes con incidencia de muerte cardiovascular (CV), infarto de miocardio (IM) o revascularización urgente (UR) durante 30 días desde la primera dosis de carga (LD)
Periodo de tiempo: Primera LD hasta 30 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte CV, IM o RU dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera LD hasta 30 días después de la primera LD
Porcentaje de participantes con incidencia de muerte cardiovascular (CV) durante 30 días desde la primera dosis de carga (LD)
Periodo de tiempo: Primera LD hasta 30 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte CV dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera LD hasta 30 días después de la primera LD
Porcentaje de participantes con incidencia de trombosis del stent (ST) definitiva o probable según los criterios del Academic Research Consortium (ARC) hasta los 30 días desde la primera dosis de carga (LD)
Periodo de tiempo: Primera LD hasta 30 días después de la primera LD
Se utilizaron los criterios ARC para definir ST. ST definitivo es la confirmación angiográfica o patológica de oclusión trombótica parcial o total dentro de la región peri-stent, y al menos uno 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. El porcentaje de participantes es el número total de participantes que experimentaron una trombosis del stent definitiva o probable dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera LD hasta 30 días después de la primera LD
Porcentaje de participantes con muerte por todas las causas, infarto de miocardio (MI), accidente cerebrovascular o injerto de derivación de toda la arteria coronaria (CABG) y trombólisis no CABG en el infarto de miocardio (TIMI) Sangrado mayor durante 30 días desde la primera dosis de carga (LD)
Periodo de tiempo: Primera LD hasta 30 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una muerte por todas las causas, infarto de miocardio, accidente cerebrovascular o CABG y sangrado mayor TIMI no CABG dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera LD hasta 30 días después de la primera LD
Cambio en la troponina estandarizada desde el inicio hasta la intervención coronaria percutánea (PCI)
Periodo de tiempo: Línea de base, antes de PCI (no más de 48 horas después de la aleatorización)
La troponina estandarizada se define como la relación entre el valor de troponina analizado dividido por el límite superior de la normalidad (LSN). Las medias de mínimos cuadrados (LS) se obtuvieron de un modelo de análisis de covarianza (ANCOVA) con tratamiento como efecto fijo y troponina estandarizada de referencia como covariable.
Línea de base, antes de PCI (no más de 48 horas después de la aleatorización)
Porcentaje de participantes con incidencia de todos los injertos de derivación de la arteria coronaria (CABG) o trombólisis no CABG en el infarto de miocardio (TIMI) Sangrado mayor
Periodo de tiempo: Primera dosis de carga (LD) hasta 7 días después de la primera LD
El porcentaje de participantes es el número total de participantes que experimentaron una hemorragia mayor TIMI CABG o no CABG dividido por el número de participantes en el brazo de tratamiento multiplicado por 100. Los eventos de punto final fueron adjudicados por el Comité de punto final clínico.
Primera dosis de carga (LD) hasta 7 días después de la primera LD

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Resumen de todas las causas de muerte
Periodo de tiempo: Aleatorización a los 30 días
Todas las muertes, independientemente de la posible relación, fueron adjudicadas por el Clinical Endpoint Committee (CEC) y se informan en esta tabla.
Aleatorización a los 30 días

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Colaboradores

Daiichi Sankyo Co., Ltd.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2009

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de febrero de 2013

Fechas de registro del estudio

Enviado por primera vez

17 de noviembre de 2009

Primero enviado que cumplió con los criterios de control de calidad

17 de noviembre de 2009

Publicado por primera vez (Estimar)

18 de noviembre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

28 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

17 de enero de 2014

Última verificación

1 de enero de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 12918
  • H7T-MC-TADF (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. .

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