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En sammenligning af Prasugrel ved PCI eller diagnosetidspunkt for ikke-ST elevation myokardieinfarkt (ACCOAST)

17. januar 2014 opdateret af: Eli Lilly and Company

En sammenligning af Prasugrel på tidspunktet for perkutan koronarintervention (PCI) eller som forbehandling på diagnosetidspunktet hos patienter med ikke-ST-elevation myokardieinfarkt (NSTEMI): ACCOAST-undersøgelsen

Formålet med dette forsøg er at undersøge de potentielle fordele/risici ved forbehandling med prasugrel ved ikke-ST-elevation myokardieinfarkt (NSTEMI) deltagere med forhøjet troponin planlagt til koronar angiografi/perkutan koronar intervention (PCI).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette forsøg består af to arme. Den ene arm er en ikke-forbehandlingsarm. Deltagere i denne arm vil modtage placebo umiddelbart efter NSTEMI-diagnose og før den diagnostiske koronar angiografi. En 60 mg prasugrel-startdosis vil blive givet umiddelbart efter koronar angiografi, når der fortsættes til PCI. Efterfølgende vil deltagerne modtage daglige vedligeholdelsesdoser af prasugrel indtil dag 30. Deltagere, der er over eller lig med 75 år, eller som har en kropsvægt på mindre end 60 kg (kg), vil modtage 5 mg oral dosis dagligt. Alle andre vil modtage en 10 mg oral daglig vedligeholdelsesdosis i 30 dage.

Den anden arm er en forbehandlingsarm, hvor deltagerne vil modtage et opdelt belastningsdosisregime med 30 mg prasugrel indgivet umiddelbart efter NSTEMI-diagnose og før diagnostisk koronar angiografi. Resten af ​​startdosis (30 mg) vil blive administreret, når deltagerne går videre til PCI. Efterfølgende vil deltagerne modtage daglige vedligeholdelsesdoser af prasugrel indtil dag 30. Deltagere, der er over eller lig med 75 år, eller som har en kropsvægt på mindre end 60 kg, vil modtage 5 mg oral dosis dagligt. Alle andre vil modtage en 10 mg oral daglig vedligeholdelsesdosis i 30 dage.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4033

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Bonheiden, Belgien, 2820
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      • Brugge, Belgien, 8000
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      • Charleroi, Belgien, 6000
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      • Genk, Belgien, 3600
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      • Leuven, Belgien, 3000
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      • Yvoir, Belgien, 5530
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  • Canada
    • Alberta
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    • Quebec
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    • Saskatchewan
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  • Finland
      • Turku, Finland, 20521
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  • Frankrig
      • Bastia, Frankrig, 20600
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      • Bron, Frankrig, 69500
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      • Caluire Et Cuire, Frankrig, 69300
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      • Cannes Cedex, Frankrig, 06401
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      • Chateauroux, Frankrig, 36019
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      • Corbeil Essonnes, Frankrig, 91106
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      • Lagny Sur Marne, Frankrig, 77405
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      • Lille, Frankrig, 59037
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      • Lyon, Frankrig, 69317
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      • Marseille, Frankrig, 13015
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      • Metz Tessy, Frankrig, 74370
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      • Pau Cedex, Frankrig, 64046
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      • Pierre Benite, Frankrig, 69495
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      • Rennes, Frankrig, 35033
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      • Toulouse, Frankrig, 31076
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      • Valence, Frankrig, 26953
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      • Vannes, Frankrig, 56017
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      • Vienne, Frankrig, 38209
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      • Villeurbanne, Frankrig, 69100
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  • Holland
      • Amsterdam, Holland, 1081 HV
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      • Eindhoven, Holland, 5623 EJ
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      • Leeuwarden, Holland, 8934 AD
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      • Nieuwegein, Holland, 3435 CM
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      • Nijmegen, Holland, 6500 HB
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      • Tiel, Holland, 4002 WP
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      • Zwolle, Holland, 8025 AB
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  • Israel
      • Beer Yaakov, Israel, 70300
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      • Haifa, Israel, 34362
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      • Jerusalem, Israel, 91120
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      • Kfar Saba, Israel, 44281
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      • Tel-Aviv, Israel, 64239
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      • Tiberias, Israel, 15208
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  • Italien
      • Arezzo, Italien, 52100
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      • Grosseto, Italien, 58100
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      • Legnano, Italien, 20025
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      • Lucca, Italien
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      • Massa, Italien, 54100
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      • Monza, Italien, 20900
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      • Napoli, Italien, 80100
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      • Perugia, Italien, 06156
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      • Pisa, Italien, 56100
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      • Prato, Italien, 50047
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      • Reggio Emilia, Italien, 42100
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      • Rome, Italien, 00100
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  • Kalkun
      • Adana, Kalkun, 1330
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      • Ankara, Kalkun, 06520
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      • Antalya, Kalkun, 07070
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      • Fatih, Kalkun, 34300
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      • Isparta, Kalkun, 32100
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      • Istanbul, Kalkun, 34303
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      • Kayseri, Kalkun, 38039
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      • Kocaeli, Kalkun, 41900
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      • Sisli, Kalkun, 34381
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  • Letland
      • Liepaja, Letland, 3414
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      • Riga, Letland, 1038
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  • Litauen
      • Kaunas, Litauen, LT-50009
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      • Klaipedos, Litauen, 92288
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      • Vilnius, Litauen, LT-08661
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  • Polen
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      • Chrzanow, Polen, 32-500
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      • Grodzisk Mazowiecki, Polen, 05-825
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      • Katowice, Polen, 40-635
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      • Klodzko, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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, Polen, 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.
  • Rumænien
      • Bucharest, Rumænien, 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, Rumænien, 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.
  • Slovakiet
      • Banska Bystrica, Slovakiet, 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, Slovakiet, 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, Slovakiet, 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.
  • Sverige
      • Goteborg, Sverige, 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.
  • Tjekkiet
      • Brno, Tjekkiet, 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, Tjekkiet, 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, Tjekkiet, 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, Tjekkiet, 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, Tjekkiet, 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, Tjekkiet, 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.
  • Tyskland
      • Bad Nauheim, Tyskland, 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, Tyskland, 23795
        • 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.
      • Bochum, Tyskland, 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, Tyskland, 53105
        • 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.
      • Coburg, Tyskland, 96450
        • 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.
      • Dachau, Tyskland, 85221
        • 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.
      • Eutin, Tyskland, 23701
        • 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.
      • Frankfurt, Tyskland, 60596
        • 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.
      • Halle, Tyskland, 06120
        • 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.
      • Hamburg, Tyskland, 20099
        • 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.
      • Hannover, Tyskland, 30625
        • 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.
      • Heidelberg, Tyskland, D-69120
        • 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.
      • Jena, Tyskland, 07740
        • 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.
      • Kassel, Tyskland, 34125
        • 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.
      • Leipzig, Tyskland, 04289
        • 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.
      • Ludwigshafen, Tyskland, 67063
        • 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.
      • Mainz, Tyskland, 55101
        • 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.
      • Munich, Tyskland, 80336
        • 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.
      • Rastatt, Tyskland, 76437
        • 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.
      • Rostock, Tyskland, 18057
        • 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.
      • Villingen-Schwenningen, Tyskland, 78050
        • 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.
  • Ungarn
      • Balatonfured, Ungarn, 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, Ungarn, 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, Ungarn, 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, Ungarn, 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.
  • Østrig
      • Braunau Am Inn, Østrig, 5280
        • 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.
      • Graz, Østrig, 8020
        • 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.
      • Linz, Østrig, 4020
        • 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.
      • Vienna, Østrig, A1090
        • 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.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

  • Har akut koronarsyndrom bestående af ikke-ST-segment elevation med forhøjet troponin
  • Planlagt til koronar angiografi/PCI større end eller lig med 2 og mindre end 24 timer fra tidspunktet for planlagt randomisering, men ikke mere end 48 timer fra randomisering
  • Skal være berettiget til behandling med prasugrel, aspirin (ASA) og en glycoprotein IIb/IIIa receptor (GPIIb/IIIa) hæmmer i henhold til de respektive mærker
  • Kan være på en vedligeholdelsesdosis af clopidogrel 75 mg og skal kunne skifte til prasugrel
  • Skal være indskrevet på et hjertekateteriseringslaboratoriehospital eller på et hospital/ambulancetjeneste tilknyttet et hjertekateteriseringslaboratoriehospital

Ekskluderingskriterier:

  • Til stede med ST-segment elevation myokardieinfarkt (STEMI) på tidspunktet for indtræden eller randomisering
  • Har kardiogent shock
  • Har refraktære ventrikulære arytmier
  • Har New York Heart Association (NYHA) klasse IV kongestiv hjertesvigt (CHF)
  • Har haft hjertestop inden for 1 uge efter indtræden eller randomisering i undersøgelsen

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ikke forbehandling
En placebo oral ladningsdosis gives på diagnosetidspunktet, og en oral dosis prasugrel på 60 milligram (mg) gives på tidspunktet for PCI efterfulgt af 5 mg eller 10 mg oral daglig vedligeholdelsesdosis prasugrel i 30 dage.
Medicin: Prasugrel
Indgives oralt
Andre navne:
  • Effektiv
  • LY640315
  • CS-747
Medicin: Placebo
Indgivet én gang oralt
Eksperimentel: Split Loading Dose
En 30 mg oral belastningsdosis prasugrel gives ved diagnose, og en 30 mg oral dosis prasugrel gives på tidspunktet for PCI efterfulgt af 5 mg eller 10 mg oral daglig vedligeholdelsesdosis prasugrel i 30 dage
Medicin: Prasugrel
Indgives oralt
Andre navne:
  • Effektiv
  • LY640315
  • CS-747

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdelen af ​​deltagere med forekomst af kardiovaskulær (CV) død, myokardieinfarkt (MI), slagtilfælde, presserende revaskularisering (UR) eller glykoprotein (GP) IIb/IIIa-hæmmer-redning
Tidsramme: Første opladningsdosis (LD) gennem 7 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever et CV-dødsfald, MI, slagtilfælde, UR eller GPIIb/IIIa-hæmmer-redning divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første opladningsdosis (LD) gennem 7 dage efter første LD

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med dødsfald af alle årsager, myokardieinfarkt (MI), slagtilfælde eller al coronary artery bypass graft (CABG) og non-CABG trombolyse i myokardieinfarkt (TIMI) større blødning
Tidsramme: Første opladningsdosis (LD) gennem 7 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever en dødsfald af alle årsager, MI, slagtilfælde eller CABG og ikke-CABG TIMI større blødning divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første opladningsdosis (LD) gennem 7 dage efter første LD
Procentdel af deltagere med forekomst af kardiovaskulær (CV) død, myokardieinfarkt (MI) eller slagtilfælde gennem 30 dage fra første belastningsdosis (LD)
Tidsramme: Første LD gennem 30 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever et CV-dødsfald, MI eller slagtilfælde divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første LD gennem 30 dage efter første LD
Procentdel af deltagere med forekomst af kardiovaskulær (CV) død eller myokardieinfarkt (MI) gennem 30 dage fra første belastningsdosis (LD)
Tidsramme: Første LD gennem 30 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever et CV-dødsfald eller MI divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første LD gennem 30 dage efter første LD
Procentdel af deltagere med forekomst af kardiovaskulær (CV) død, myokardieinfarkt (MI) eller akut revaskularisering (UR) gennem 30 dage fra første belastningsdosis (LD)
Tidsramme: Første LD gennem 30 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever et CV-dødsfald, MI eller UR divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første LD gennem 30 dage efter første LD
Procentdel af deltagere med forekomst af kardiovaskulær (CV) død gennem 30 dage fra første indlæsningsdosis (LD)
Tidsramme: Første LD gennem 30 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever et CV-dødsfald divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første LD gennem 30 dage efter første LD
Procentdel af deltagere med forekomst af bestemt eller sandsynlig stenttrombose (ST) i henhold til kriterierne for Academic Research Consortium (ARC) gennem 30 dage fra første indlæsningsdosis (LD)
Tidsramme: Første LD gennem 30 dage efter første LD
ARC-kriterier blev brugt til at definere ST. Definite ST er angiografisk eller patologisk bekræftelse af delvis eller total trombotisk okklusion i peri-stentregionen og mindst et af følgende yderligere kriterier: akutte iskæmiske symptomer; iskæmiske elektrokardiogram ændringer; forhøjede hjertebiomarkører. Sandsynlig ST er enhver uforklarlig død inden for 30 dage efter stentimplantation; enhver MI, som er relateret til dokumenteret akut iskæmi i den implanterede stents territorium uden angiografisk bekræftelse af ST og i fravær af anden åbenbar årsag. Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever en sikker eller sandsynlig stenttrombose divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første LD gennem 30 dage efter første LD
Procentdel af deltagere med dødsfald af alle årsager, myokardieinfarkt (MI), slagtilfælde eller bypasstransplantat (CABG) og non-CABG trombolyse ved myokardieinfarkt (TIMI) større blødninger gennem 30 dage fra første belastningsdosis (LD)
Tidsramme: Første LD gennem 30 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever en dødsfald af alle årsager, MI, slagtilfælde eller CABG og ikke-CABG TIMI større blødning divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første LD gennem 30 dage efter første LD
Ændring i standardiseret troponin fra baseline til perkutan koronar intervention (PCI)
Tidsramme: Baseline, før PCI (ikke mere end 48 timer efter randomisering)
Standardiseret troponin er defineret som forholdet mellem den analyserede troponinværdi divideret med den øvre normalgrænse (ULN). Mindste kvadraters (LS) gennemsnit blev opnået fra en analyse af kovarians (ANCOVA) model med behandling som en fast effekt og baseline standardiseret troponin som en kovariat.
Baseline, før PCI (ikke mere end 48 timer efter randomisering)
Procentdel af deltagere med forekomst af alle koronararterie bypasstransplantater (CABG) eller ikke-CABG trombolyse i myokardieinfarkt (TIMI) større blødninger
Tidsramme: Første opladningsdosis (LD) gennem 7 dage efter første LD
Procentdelen af ​​deltagere er det samlede antal deltagere, der oplever en CABG eller ikke-CABG TIMI større blødning divideret med antallet af deltagere i behandlingsarmen ganget med 100. Endpoint-hændelser blev bedømt af Clinical Endpoint Committee.
Første opladningsdosis (LD) gennem 7 dage efter første LD

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sammenfatning af Død af alle årsager
Tidsramme: Randomisering gennem 30 dage
Alle dødsfald, uanset mulig slægtskab, blev dømt af Clinical Endpoint Committee (CEC) og er rapporteret i denne tabel.
Randomisering gennem 30 dage

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Samarbejdspartnere

Daiichi Sankyo Co., Ltd.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2009

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

17. november 2009

Først indsendt, der opfyldte QC-kriterier

17. november 2009

Først opslået (Skøn)

18. november 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12918
  • H7T-MC-TADF (Anden identifikator: Eli Lilly and Company)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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