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Un confronto tra Prasugrel al PCI o al momento della diagnosi di infarto miocardico senza sopraslivellamento del tratto ST (ACCOAST)

17 gennaio 2014 aggiornato da: Eli Lilly and Company

Un confronto tra prasugrel al momento dell'intervento coronarico percutaneo (PCI) o come pretrattamento al momento della diagnosi in pazienti con infarto miocardico senza sopraslivellamento del tratto ST (NSTEMI): lo studio ACCOAST

Lo scopo di questo studio è quello di indagare i potenziali benefici/rischi relativi al pretrattamento con prasugrel nei partecipanti con infarto del miocardio senza sopraslivellamento del tratto ST (NSTEMI) con troponina elevata in attesa di angiografia coronarica/intervento coronarico percutaneo (PCI).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Questo processo è composto da due bracci. Un braccio è un braccio non pre-trattamento. I partecipanti a questo braccio riceveranno il placebo immediatamente dopo la diagnosi di NSTEMI e prima dell'angiografia coronarica diagnostica. Una dose di carico di 60 mg di prasugrel verrà somministrata immediatamente dopo l'angiografia coronarica quando si procede al PCI. Successivamente, i partecipanti riceveranno dosi giornaliere di mantenimento di prasugrel fino al giorno 30. I partecipanti di età superiore o uguale a 75 anni o che hanno un peso corporeo inferiore a 60 chilogrammi (kg) riceveranno una dose orale di 5 mg al giorno. Tutti gli altri riceveranno una dose orale giornaliera di mantenimento di 10 mg per 30 giorni.

L'altro braccio è un braccio di pre-trattamento in cui i partecipanti riceveranno un regime di dose di carico frazionato con 30 mg di prasugrel somministrato immediatamente dopo la diagnosi di NSTEMI e prima dell'angiografia coronarica diagnostica. Il resto della dose di carico (30 mg) verrà somministrato quando i partecipanti procederanno al PCI. Successivamente, i partecipanti riceveranno dosi giornaliere di mantenimento di prasugrel fino al giorno 30. I partecipanti di età superiore o uguale a 75 anni o che hanno un peso corporeo inferiore a 60 kg riceveranno una dose orale di 5 mg al giorno. Tutti gli altri riceveranno una dose orale giornaliera di mantenimento di 10 mg per 30 giorni.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4033

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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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  • Belgio
      • Bonheiden, Belgio, 2820
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      • Brugge, Belgio, 8000
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      • Charleroi, Belgio, 6000
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      • Genk, Belgio, 3600
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      • Leuven, Belgio, 3000
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      • Yvoir, Belgio, 5530
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  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
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    • British Columbia
      • Vancouver, British Columbia, Canada, Vancouver
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    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
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    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
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      • Sainte-Foy, Quebec, Canada, G1V 4G5
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    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
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  • Finlandia
      • Turku, Finlandia, 20521
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  • Francia
      • Bastia, Francia, 20600
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      • Bron, Francia, 69500
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      • Caluire Et Cuire, Francia, 69300
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      • 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
        • 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.
  • Germania
      • Bad Nauheim, Germania, 61231
        • 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.
      • Bad Segeberg, Germania, 23795
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      • Bochum, Germania, 44791
        • 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.
      • Bonn, Germania, 53105
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      • Coburg, Germania, 96450
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      • Dachau, Germania, 85221
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      • Eutin, Germania, 23701
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      • Frankfurt, Germania, 60596
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      • Halle, Germania, 06120
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      • Hamburg, Germania, 20099
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      • Hannover, Germania, 30625
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      • Heidelberg, Germania, D-69120
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      • Jena, Germania, 07740
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      • Kassel, Germania, 34125
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      • Leipzig, Germania, 04289
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      • Ludwigshafen, Germania, 67063
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      • Mainz, Germania, 55101
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      • Munich, Germania, 80336
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      • Rastatt, Germania, 76437
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      • Rostock, Germania, 18057
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      • Villingen-Schwenningen, Germania, 78050
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  • Israele
      • Beer Yaakov, Israele, 70300
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      • Haifa, Israele, 34362
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      • Jerusalem, Israele, 91120
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      • Kfar Saba, Israele, 44281
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      • Nahariya, Israele, 22100
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      • Tel-Aviv, Israele, 64239
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      • Tiberias, Israele, 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
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      • Pisa, Italia, 56100
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      • Prato, Italia, 50047
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      • Reggio Emilia, Italia, 42100
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      • Rome, Italia, 00100
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      • Torino, Italia, 10100
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      • Udine, Italia, 33100
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      • 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.
  • Lettonia
      • Liepaja, Lettonia, 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, Lettonia, 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.
  • Olanda
      • Amsterdam, Olanda, 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, Olanda, 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, Olanda, 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, Olanda, 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, Olanda, 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, Olanda, 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, Olanda, 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.
  • Portogallo
      • Braga, Portogallo, 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, Portogallo, 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, Portogallo, 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, Portogallo, 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.
  • Repubblica Ceca
      • Brno, Repubblica Ceca, 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, Repubblica Ceca, 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, Repubblica Ceca, 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, Repubblica Ceca, 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, Repubblica Ceca, 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, Repubblica Ceca, 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.
  • Romania
      • Bucharest, Romania, 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, Romania, 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.
  • Slovacchia
      • Banska Bystrica, Slovacchia, 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, Slovacchia, 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, Slovacchia, 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.
  • Svezia
      • Goteborg, Svezia, 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.
  • Tacchino
      • Adana, Tacchino, 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, Tacchino, 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, Tacchino, 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, Tacchino, 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, Tacchino, 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, Tacchino, 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, Tacchino, 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, Tacchino, 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, Tacchino, 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.
  • Ungheria
      • Balatonfured, Ungheria, 8230
        • 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.
      • Budapest, Ungheria, 1096
        • 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.
      • Pecs, Ungheria, 7624
        • 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.
      • Zalaegerszeg, Ungheria, 8900
        • 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.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Criterio di inclusione:

  • Avere una sindrome coronarica acuta consistente in un sopraslivellamento senza tratto ST con troponina elevata
  • Programmato per angiografia coronarica/PCI superiore o uguale a 2 e inferiore a 24 ore dal momento della randomizzazione pianificata, ma non più di 48 ore dalla randomizzazione
  • Deve essere idoneo per il trattamento con prasugrel, aspirina (ASA) e un inibitore del recettore della glicoproteina IIb/IIIa (GPIIb/IIIa) secondo le rispettive etichette
  • Può assumere una dose di mantenimento di clopidogrel 75 mg e deve essere in grado di passare a prasugrel
  • Deve essere arruolato presso un ospedale laboratorio di cateterismo cardiaco o presso un ospedale/servizio di ambulanza affiliato a un ospedale laboratorio di cateterismo cardiaco

Criteri di esclusione:

  • Presente con infarto del miocardio con sopraslivellamento del segmento ST (STEMI) al momento dell'ingresso o della randomizzazione
  • Avere uno shock cardiogeno
  • Avere aritmie ventricolari refrattarie
  • Avere insufficienza cardiaca congestizia (CHF) di classe IV della New York Heart Association (NYHA)
  • - Hanno avuto un arresto cardiaco entro 1 settimana dall'ingresso o dalla randomizzazione nello studio

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Non pretrattamento
Una dose di carico orale di placebo viene somministrata al momento della diagnosi e una dose di carico orale di 60 milligrammi (mg) di prasugrel viene somministrata al momento della PCI, seguita da una dose orale giornaliera di mantenimento di 5 mg o 10 mg di prasugrel per 30 giorni.
Droga: Prasugrel
Somministrato per via orale
Altri nomi:
  • Efficiente
  • LY640315
  • CS-747
  • Efficace
Droga: Placebo
Somministrato una volta per via orale
Sperimentale: Dose di caricamento divisa
Una dose orale di carico di 30 mg di prasugrel viene somministrata alla diagnosi e una dose orale di 30 mg di prasugrel viene somministrata al momento della PCI seguita da una dose orale giornaliera di mantenimento di 5 mg o 10 mg di prasugrel per 30 giorni
Droga: Prasugrel
Somministrato per via orale
Altri nomi:
  • Efficiente
  • LY640315
  • CS-747
  • Efficace

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
La percentuale di partecipanti con insorgenza di morte cardiovascolare (CV), infarto del miocardio (IM), ictus, rivascolarizzazione urgente (UR) o salvataggio dell'inibitore della glicoproteina (GP) IIb/IIIa
Lasso di tempo: Prima dose di carico (LD) fino a 7 giorni dopo la prima LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno subito un salvataggio per morte CV, infarto del miocardio, ictus, UR o inibitore GPIIb/IIIa diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Prima dose di carico (LD) fino a 7 giorni dopo la prima LD

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentuale di partecipanti con morte per tutte le cause, infarto miocardico (MI), ictus o trapianto di bypass coronarico (CABG) e sanguinamento maggiore non CABG nell'infarto miocardico (TIMI)
Lasso di tempo: Prima dose di carico (LD) fino a 7 giorni dopo la prima LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno avuto morte per tutte le cause, IM, ictus o CABG e sanguinamento maggiore TIMI non-CABG diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Prima dose di carico (LD) fino a 7 giorni dopo la prima LD
Percentuale di partecipanti con incidenza di morte cardiovascolare (CV), infarto del miocardio (IM) o ictus nei 30 giorni dalla prima dose di carico (LD)
Lasso di tempo: Dal primo LD fino a 30 giorni dopo il primo LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno avuto un decesso CV, IM o ictus diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Dal primo LD fino a 30 giorni dopo il primo LD
Percentuale di partecipanti con incidenza di morte cardiovascolare (CV) o infarto miocardico (MI) fino a 30 giorni dalla prima dose di carico (LD)
Lasso di tempo: Dal primo LD fino a 30 giorni dopo il primo LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno subito un decesso CV o IM diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Dal primo LD fino a 30 giorni dopo il primo LD
Percentuale di partecipanti con incidenza di morte cardiovascolare (CV), infarto miocardico (IM) o rivascolarizzazione urgente (UR) a 30 giorni dalla prima dose di carico (LD)
Lasso di tempo: Dal primo LD fino a 30 giorni dopo il primo LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno subito un decesso CV, IM o UR diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Dal primo LD fino a 30 giorni dopo il primo LD
Percentuale di partecipanti con incidenza di morte cardiovascolare (CV) fino a 30 giorni dalla prima dose di carico (LD)
Lasso di tempo: Dal primo LD fino a 30 giorni dopo il primo LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno subito un decesso CV diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Dal primo LD fino a 30 giorni dopo il primo LD
Percentuale di partecipanti con incidenza di trombosi dello stent definita o probabile (ST) secondo i criteri dell'Academic Research Consortium (ARC) a 30 giorni dalla prima dose di carico (LD)
Lasso di tempo: Dal primo LD fino a 30 giorni dopo il primo LD
I criteri ARC sono stati utilizzati per definire ST. ST definito è la conferma angiografica o patologica dell'occlusione trombotica parziale o totale all'interno della regione peri-stent e almeno uno dei seguenti criteri aggiuntivi: sintomi ischemici acuti; alterazioni dell'elettrocardiogramma ischemico; biomarcatori cardiaci elevati. Probabile ST è qualsiasi morte inspiegabile entro 30 giorni dall'impianto dello stent; qualsiasi IM, correlato a ischemia acuta documentata nel territorio dello stent impiantato senza conferma angiografica di ST e in assenza di qualsiasi altra causa evidente. La percentuale di partecipanti è il numero totale di partecipanti che hanno manifestato una trombosi dello stent definita o probabile diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Dal primo LD fino a 30 giorni dopo il primo LD
Percentuale di partecipanti con morte per tutte le cause, infarto del miocardio (IM), ictus o trapianto di bypass coronarico (CABG) e trombolisi non CABG nell'infarto del miocardio (TIMI) sanguinamento maggiore a 30 giorni dalla prima dose di carico (LD)
Lasso di tempo: Dal primo LD fino a 30 giorni dopo il primo LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno avuto morte per tutte le cause, IM, ictus o CABG e sanguinamento maggiore TIMI non-CABG diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Dal primo LD fino a 30 giorni dopo il primo LD
Variazione della troponina standardizzata dal basale all'intervento coronarico percutaneo (PCI)
Lasso di tempo: Basale, prima del PCI (non superiore a 48 ore dopo la randomizzazione)
La troponina standardizzata è definita come il rapporto tra il valore di troponina dosato diviso per il limite superiore della norma (ULN). Le medie dei minimi quadrati (LS) sono state ottenute da un modello di analisi della covarianza (ANCOVA) con trattamento come effetto fisso e troponina standardizzata al basale come covariata.
Basale, prima del PCI (non superiore a 48 ore dopo la randomizzazione)
Percentuale di partecipanti con incidenza di tutti i bypass coronarici (CABG) o trombolisi non CABG nell'infarto miocardico (TIMI) sanguinamento maggiore
Lasso di tempo: Prima dose di carico (LD) fino a 7 giorni dopo la prima LD
La percentuale di partecipanti è il numero totale di partecipanti che hanno avuto un sanguinamento maggiore TIMI CABG o non-CABG diviso per il numero di partecipanti nel braccio di trattamento moltiplicato per 100. Gli eventi dell'endpoint sono stati giudicati dal comitato degli endpoint clinici.
Prima dose di carico (LD) fino a 7 giorni dopo la prima LD

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Riepilogo della morte per tutte le cause
Lasso di tempo: Randomizzazione per 30 giorni
Tutti i decessi, indipendentemente dalla possibile correlazione, sono stati giudicati dal Comitato per gli endpoint clinici (CEC) e sono riportati in questa tabella.
Randomizzazione per 30 giorni

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Collaboratori

Daiichi Sankyo Co., Ltd.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2009

Completamento primario (Effettivo)

1 gennaio 2013

Completamento dello studio (Effettivo)

1 febbraio 2013

Date di iscrizione allo studio

Primo inviato

17 novembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

17 novembre 2009

Primo Inserito (Stima)

18 novembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 febbraio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 gennaio 2014

Ultimo verificato

1 gennaio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 12918
  • H7T-MC-TADF (Altro identificatore: Eli Lilly and Company)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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