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En sammenligning av Prasugrel ved PCI eller diagnosetidspunkt for hjerteinfarkt uten ST Elevation (ACCOAST)

17. januar 2014 oppdatert av: Eli Lilly and Company

En sammenligning av Prasugrel på tidspunktet for perkutan koronar intervensjon (PCI) eller som forbehandling på tidspunktet for diagnose hos pasienter med ikke-ST-elevasjonsmyokardinfarkt (NSTEMI): ACCOAST-studien

Hensikten med denne studien er å undersøke potensielle fordeler/risikoer knyttet til forbehandling med prasugrel ved ikke-ST-elevasjonsmyokardinfarkt (NSTEMI) deltakere med forhøyet troponin planlagt for koronar angiografi/perkutan koronar intervensjon (PCI).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Denne rettssaken består av to armer. Den ene armen er en arm uten forbehandling. Deltakere i denne armen vil få placebo umiddelbart etter NSTEMI-diagnose og før den diagnostiske koronar angiografi. En startdose på 60 mg prasugrel vil gis umiddelbart etter koronar angiografi når du fortsetter til PCI. Deretter vil deltakerne motta daglige vedlikeholdsdoser av prasugrel frem til dag 30. Deltakere som er eldre enn eller lik 75 år eller som har en kroppsvekt mindre enn 60 kilogram (kg) vil få 5 mg oral dose daglig. Alle andre vil motta en 10 mg oral daglig vedlikeholdsdose i 30 dager.

Den andre armen er en forbehandlingsarm hvor deltakerne vil motta et delt belastningsdoseregime med 30 mg prasugrel administrert umiddelbart etter NSTEMI-diagnose og før diagnostisk koronar angiografi. Resten av startdosen (30 mg) vil bli administrert når deltakerne går videre til PCI. Deretter vil deltakerne motta daglige vedlikeholdsdoser av prasugrel frem til dag 30. Deltakere som er eldre enn eller lik 75 år eller som har en kroppsvekt mindre enn 60 kg vil få 5 mg oral dose daglig. Alle andre vil motta en 10 mg oral daglig vedlikeholdsdose i 30 dager.

Studietype

Intervensjonell

Registrering (Faktiske)

4033

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Bonheiden, Belgia, 2820
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      • Brugge, Belgia, 8000
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      • Charleroi, Belgia, 6000
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      • Genk, Belgia, 3600
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      • Leuven, Belgia, 3000
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      • Yvoir, Belgia, 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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  • Finland
      • Turku, Finland, 20521
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  • Frankrike
      • Bastia, Frankrike, 20600
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      • Bron, Frankrike, 69500
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      • Caluire Et Cuire, Frankrike, 69300
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      • Cannes Cedex, Frankrike, 06401
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      • Chateauroux, Frankrike, 36019
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      • Corbeil Essonnes, Frankrike, 91106
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      • Lagny Sur Marne, Frankrike, 77405
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      • Le Coudray, Frankrike, 28630
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      • Lille, Frankrike, 59037
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      • Lyon, Frankrike, 69317
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      • Marseille, Frankrike, 13015
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      • Metz, Frankrike, 57085
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      • Metz Tessy, Frankrike, 74370
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      • Montauban, Frankrike, 82017
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      • Montreuil, Frankrike, 93105
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      • Nimes, Frankrike, 30029
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      • Paris, Frankrike, 75743
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      • Pau Cedex, Frankrike, 64046
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      • Pierre Benite, Frankrike, 69495
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      • Rennes, Frankrike, 35033
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      • Toulouse, Frankrike, 31076
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      • Valence, Frankrike, 26953
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      • Vannes, Frankrike, 56017
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      • Vienne, Frankrike, 38209
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      • Villeurbanne, Frankrike, 69100
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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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      • 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
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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
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  • Latvia
      • Liepaja, Latvia, 3414
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      • Riga, Latvia, 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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  • Nederland
      • Amsterdam, Nederland, 1081 HV
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      • Eindhoven, Nederland, 5623 EJ
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      • Leeuwarden, Nederland, 8934 AD
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      • Nieuwegein, Nederland, 3435 CM
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      • Nijmegen, Nederland, 6500 HB
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      • Tiel, Nederland, 4002 WP
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      • Zwolle, Nederland, 8025 AB
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  • Polen
      • Belchatow, Polen, 97-400
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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
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      • Krakow, Polen, 31-501
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      • Lodz, Polen, 91-347
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      • Lublin, Polen, 20-954
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      • Mielec, Polen, 39-300
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      • Naleczow, Polen, 24-140
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      • Nowy Sacz, Polen, 33-300
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      • Nowy Targ, Polen, 34-400
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      • 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.
  • 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.
  • Slovakia
      • Banska Bystrica, Slovakia, 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, Slovakia, 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, Slovakia, 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.
  • Tsjekkisk Republikk
      • Brno, Tsjekkisk Republikk, 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, Tsjekkisk Republikk, 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, Tsjekkisk Republikk, 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, Tsjekkisk Republikk, 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, Tsjekkisk Republikk, 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, Tsjekkisk Republikk, 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.
  • Tyrkia
      • Adana, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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, Tyrkia, 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.
  • 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.
  • Østerrike
      • Braunau Am Inn, Østerrike, 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, Østerrike, 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, Østerrike, 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, Østerrike, 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.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inklusjonskriterier:

  • Har akutt koronarsyndrom bestående av ikke-ST-segmentheving med forhøyet troponin
  • Planlagt for koronar angiografi/PCI større enn eller lik 2 og mindre enn 24 timer fra tidspunktet for planlagt randomisering, men ikke mer enn 48 timer fra randomisering
  • Må være kvalifisert for behandling med prasugrel, aspirin (ASA) og en glykoprotein IIb/IIIa reseptor (GPIIb/IIIa) hemmer i henhold til respektive etiketter
  • Kan være på en vedlikeholdsdose av klopidogrel 75 mg og må kunne bytte til prasugrel
  • Må være innskrevet ved et hjertekateteriseringslaboratorium eller ved et sykehus/ambulansetjeneste tilknyttet et hjertekateteriseringslaboratorium

Ekskluderingskriterier:

  • Tilstede med ST-segment elevation myokardinfarkt (STEMI) på tidspunktet for inntreden eller randomisering
  • Har kardiogent sjokk
  • Har refraktære ventrikulære arytmier
  • Har New York Heart Association (NYHA) klasse IV kongestiv hjertesvikt (CHF)
  • Har hatt hjertestans innen 1 uke etter inntreden eller randomisering i studien

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Ikke forbehandling
En oral belastningsdose med placebo gis ved diagnosetidspunktet og en oral belastningsdose på 60 mg prasugrel gis ved PCI-tidspunktet etterfulgt av 5 mg eller 10 mg oral daglig vedlikeholdsdose av prasugrel i 30 dager.
Legemiddel: Prasugrel
Administrert oralt
Andre navn:
  • Effektiv
  • LY640315
  • CS-747
Legemiddel: Placebo
Administrert en gang oralt
Eksperimentell: Delt lastedose
En 30 mg oral belastningsdose av prasugrel gis ved diagnose og en 30 mg oral dose prasugrel gis på tidspunktet for PCI etterfulgt av 5 mg eller 10 mg oral daglig vedlikeholdsdose av prasugrel i 30 dager
Legemiddel: Prasugrel
Administrert oralt
Andre navn:
  • Effektiv
  • LY640315
  • CS-747

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandelen av deltakere med forekomst av kardiovaskulær (CV) død, hjerteinfarkt (MI), hjerneslag, akutt revaskularisering (UR) eller glykoprotein (GP) IIb/IIIa-hemmer-redning
Tidsramme: Første ladningsdose (LD) til og med 7 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever CV-dødsfall, MI, hjerneslag, UR eller GPIIb/IIIa-hemmer-redning delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første ladningsdose (LD) til og med 7 dager etter første LD

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med dødsfall av alle årsaker, hjerteinfarkt (MI), hjerneslag eller all coronary artery bypass graft (CABG) og ikke-CABG trombolyse i hjerteinfarkt (TIMI) alvorlig blødning
Tidsramme: Første ladningsdose (LD) til og med 7 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever dødsfall av alle årsaker, MI, hjerneslag eller CABG og ikke-CABG TIMI større blødninger delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første ladningsdose (LD) til og med 7 dager etter første LD
Prosentandel av deltakere med forekomst av kardiovaskulær (CV) død, hjerteinfarkt (MI) eller hjerneslag gjennom 30 dager fra første belastningsdose (LD)
Tidsramme: Første LD gjennom 30 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever CV-dødsfall, MI eller hjerneslag delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første LD gjennom 30 dager etter første LD
Prosentandel av deltakere med forekomst av kardiovaskulær (CV) død eller hjerteinfarkt (MI) gjennom 30 dager fra første belastningsdose (LD)
Tidsramme: Første LD gjennom 30 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever en CV-død eller MI delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første LD gjennom 30 dager etter første LD
Prosentandel av deltakere med forekomst av kardiovaskulær (CV) død, hjerteinfarkt (MI) eller akutt revaskularisering (UR) gjennom 30 dager fra første belastningsdose (LD)
Tidsramme: Første LD gjennom 30 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever en CV-død, MI eller UR delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første LD gjennom 30 dager etter første LD
Prosentandel av deltakere med forekomst av kardiovaskulær (CV) død gjennom 30 dager fra første belastningsdose (LD)
Tidsramme: Første LD gjennom 30 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever en CV-død delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første LD gjennom 30 dager etter første LD
Prosentandel av deltakere med forekomst av bestemt eller sannsynlig stenttrombose (ST) i henhold til kriteriene for Academic Research Consortium (ARC) gjennom 30 dager fra første innlastingsdose (LD)
Tidsramme: Første LD gjennom 30 dager etter første LD
ARC-kriterier ble brukt for å definere ST. Definitiv ST er angiografisk eller patologisk bekreftelse på delvis eller total trombotisk okklusjon i peri-stentregionen, og minst ett av følgende tilleggskriterier: akutte iskemiske symptomer; iskemiske elektrokardiogram endringer; forhøyede hjertebiomarkører. Sannsynlig ST er enhver uforklarlig død innen 30 dager etter stentimplantasjon; enhver MI, som er relatert til dokumentert akutt iskemi i territoriet til den implanterte stenten uten angiografisk bekreftelse av ST og i fravær av annen åpenbar årsak. Prosentandelen av deltakere er det totale antallet deltakere som opplever en sikker eller sannsynlig stenttrombose delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første LD gjennom 30 dager etter første LD
Prosentandel av deltakere med dødsfall av alle årsaker, hjerteinfarkt (MI), hjerneslag eller all koronar bypassgraft (CABG) og ikke-CABG trombolyse ved hjerteinfarkt (TIMI) større blødninger gjennom 30 dager fra første belastningsdose (LD)
Tidsramme: Første LD gjennom 30 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever dødsfall av alle årsaker, MI, hjerneslag eller CABG og ikke-CABG TIMI større blødninger delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første LD gjennom 30 dager etter første LD
Endring i standardisert troponin fra baseline til perkutan koronar intervensjon (PCI)
Tidsramme: Grunnlinje, før PCI (ikke mer enn 48 timer etter randomisering)
Standardisert troponin er definert som forholdet mellom den analyserte troponinverdien delt på øvre normalgrense (ULN). Minste kvadraters (LS) gjennomsnitt ble hentet fra en analyse av kovarians (ANCOVA) modell med behandling som en fast effekt og baseline standardisert troponin som en kovariat.
Grunnlinje, før PCI (ikke mer enn 48 timer etter randomisering)
Prosentandel av deltakere med forekomst av all koronar bypassgraft (CABG) eller ikke-CABG trombolyse ved hjerteinfarkt (TIMI) alvorlig blødning
Tidsramme: Første ladningsdose (LD) til og med 7 dager etter første LD
Prosentandelen av deltakere er det totale antallet deltakere som opplever en CABG eller ikke-CABG TIMI større blødning delt på antall deltakere i behandlingsarmen multiplisert med 100. Endpoint-hendelser ble bedømt av Clinical Endpoint Committee.
Første ladningsdose (LD) til og med 7 dager etter første LD

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sammendrag av Død av alle årsaker
Tidsramme: Randomisering gjennom 30 dager
Alle dødsfall, uavhengig av mulig slektskap, ble dømt av Clinical Endpoint Committee (CEC) og er rapportert i denne tabellen.
Randomisering gjennom 30 dager

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Samarbeidspartnere

Daiichi Sankyo Co., Ltd.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2009

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først innsendt

17. november 2009

Først innsendt som oppfylte QC-kriteriene

17. november 2009

Først lagt ut (Anslag)

18. november 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. januar 2014

Sist bekreftet

1. januar 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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