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En jämförelse av Prasugrel vid PCI eller tidpunkt för diagnos av icke-ST-höjning hjärtinfarkt (ACCOAST)

17 januari 2014 uppdaterad av: Eli Lilly and Company

En jämförelse av Prasugrel vid tidpunkten för perkutan kranskärlsintervention (PCI) eller som förbehandling vid tidpunkten för diagnos hos patienter med icke-ST-förhöjd hjärtinfarkt (NSTEMI): ACCOAST-studien

Syftet med denna studie är att undersöka de potentiella fördelarna/riskerna med förbehandling med prasugrel vid icke-ST-förhöjd hjärtinfarkt (NSTEMI) deltagare med förhöjt troponin planerat för koronar angiografi/perkutan koronar intervention (PCI).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Denna rättegång består av två armar. En arm är en arm utan förbehandling. Deltagare i denna arm kommer att få placebo omedelbart efter NSTEMI-diagnostik och före den diagnostiska kranskärlsangiografin. En laddningsdos på 60 mg prasugrel kommer att ges omedelbart efter kranskärlsangiografi när man fortsätter till PCI. Därefter kommer deltagarna att få dagliga underhållsdoser av prasugrel fram till dag 30. Deltagare som är äldre än eller lika med 75 år eller som har en kroppsvikt mindre än 60 kg (kg) kommer att få 5 mg oral dos dagligen. Alla andra kommer att få en 10 mg oral daglig underhållsdos i 30 dagar.

Den andra armen är en förbehandlingsarm där deltagarna kommer att få en delad laddningsdosregim med 30 mg prasugrel administrerat omedelbart efter NSTEMI-diagnos och före diagnostisk koronar angiografi. Resten av laddningsdosen (30 mg) kommer att administreras när deltagarna går vidare till PCI. Därefter kommer deltagarna att få dagliga underhållsdoser av prasugrel fram till dag 30. Deltagare som är äldre än eller lika med 75 år eller som har en kroppsvikt mindre än 60 kg kommer att få 5 mg oral dos dagligen. Alla andra kommer att få en 10 mg oral daglig underhållsdos i 30 dagar.

Studietyp

Interventionell

Inskrivning (Faktisk)

4033

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Belgien
      • Bonheiden, Belgien, 2820
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      • Brugge, Belgien, 8000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Charleroi, Belgien, 6000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Genk, Belgien, 3600
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      • Leuven, Belgien, 3000
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      • Yvoir, Belgien, 5530
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Finland
      • Turku, Finland, 20521
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Frankrike
      • Bastia, Frankrike, 20600
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bron, Frankrike, 69500
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      • Caluire Et Cuire, Frankrike, 69300
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cannes Cedex, 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
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pierre Benite, Frankrike, 69495
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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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  • Italien
      • Arezzo, Italien, 52100
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      • Chieti, Italien, 66013
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • 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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      • Pavia, Italien, 27100
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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
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rome, Italien, 00100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Torino, Italien, 10100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Udine, Italien, 33100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Venezia, Italien, 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.
  • Kalkon
      • Adana, Kalkon, 1330
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      • Ankara, Kalkon, 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, Kalkon, 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, Kalkon, 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, Kalkon, 32100
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      • Istanbul, Kalkon, 34303
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      • Kayseri, Kalkon, 38039
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      • Kocaeli, Kalkon, 41900
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      • Sisli, Kalkon, 34381
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  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 2T9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • British Columbia
      • Vancouver, British Columbia, Kanada, Vancouver
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    • Ontario
      • Toronto, Ontario, Kanada, M5B 1W8
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    • Quebec
      • Montreal, Quebec, Kanada, H4J 1C5
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      • Sainte-Foy, Quebec, Kanada, G1V 4G5
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    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7N 0W8
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  • Lettland
      • Liepaja, Lettland, 3414
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      • Riga, Lettland, 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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  • Nederländerna
      • Amsterdam, Nederländerna, 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, Nederländerna, 5623 EJ
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      • Leeuwarden, Nederländerna, 8934 AD
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      • Nieuwegein, Nederländerna, 3435 CM
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      • Nijmegen, Nederländerna, 6500 HB
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      • Tiel, Nederländerna, 4002 WP
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      • Zwolle, Nederländerna, 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.
  • 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
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Klodzko, 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.
  • Rumänien
      • Bucharest, Rumänien, 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, Rumänien, 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.
  • Slovakien
      • Banska Bystrica, Slovakien, 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, Slovakien, 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, Slovakien, 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.
  • Tjeckien
      • Brno, Tjeckien, 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, Tjeckien, 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, Tjeckien, 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, Tjeckien, 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, Tjeckien, 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, Tjeckien, 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.
  • Ungern
      • Balatonfured, Ungern, 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, Ungern, 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, Ungern, 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, Ungern, 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.
  • Österrike
      • Braunau Am Inn, Österrike, 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, Österrike, 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, Österrike, 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, Österrike, 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.

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inklusionskriterier:

  • Har akut kranskärlssyndrom bestående av icke-ST-segmentförhöjning med förhöjt troponin
  • Schemalagd för koronar angiografi/PCI större än eller lika med 2 och mindre än 24 timmar från tidpunkten för planerad randomisering, men inte mer än 48 timmar från randomisering
  • Måste vara kvalificerad för behandling med prasugrel, aspirin (ASA) och en glykoprotein IIb/IIIa-receptor (GPIIb/IIIa)-hämmare enligt respektive etikett
  • Kan vara på en underhållsdos av klopidogrel 75 mg och måste kunna byta till prasugrel
  • Måste vara inskriven på ett hjärtkateteriseringslaboratorium eller på ett sjukhus/ambulanstjänst anslutet till ett hjärtkateteriseringslaboratorium

Exklusions kriterier:

  • Presenteras med hjärtinfarkt med ST-segment elevation (STEMI) vid tidpunkten för inträde eller randomisering
  • Har kardiogen chock
  • Har refraktära ventrikulära arytmier
  • Har New York Heart Association (NYHA) Klass IV hjärtsvikt (CHF)
  • Har haft hjärtstillestånd inom 1 vecka efter inträde eller randomisering i studien

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Icke förbehandling
En oral laddningsdos med placebo ges vid tidpunkten för diagnos och en oral laddningsdos på 60 mg prasugrel ges vid tidpunkten för PCI följt av 5 mg eller 10 mg oral daglig underhållsdos av prasugrel under 30 dagar.
Läkemedel: Prasugrel
Administreras oralt
Andra namn:
  • Effektiv
  • LY640315
  • CS-747
Läkemedel: Placebo
Administreras en gång oralt
Experimentell: Delad laddningsdos
En 30 mg oral laddningsdos av prasugrel ges vid diagnos och en 30 mg oral dos av prasugrel ges vid tidpunkten för PCI följt av 5 mg eller 10 mg oral daglig underhållsdos av prasugrel under 30 dagar
Läkemedel: Prasugrel
Administreras oralt
Andra namn:
  • Effektiv
  • LY640315
  • CS-747

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Andelen deltagare med förekomst av kardiovaskulär (CV) död, hjärtinfarkt (MI), stroke, akut revaskularisering (UR) eller glykoprotein (GP) IIb/IIIa-hämmare räddningsaktion
Tidsram: Första laddningsdosen (LD) till och med 7 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en CV-död, hjärtinfarkt, stroke, UR eller GPIIb/IIIa-hämmare delat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första laddningsdosen (LD) till och med 7 dagar efter första LD

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Procentandel av deltagare med dödsfall av alla orsaker, hjärtinfarkt (MI), stroke eller bypasstransplantat (CABG) och icke-CABG trombolys vid stora blödningar i hjärtinfarkt (TIMI)
Tidsram: Första laddningsdosen (LD) till och med 7 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en dödsfall av alla orsaker, MI, stroke eller CABG och icke-CABG TIMI större blödning dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första laddningsdosen (LD) till och med 7 dagar efter första LD
Andel deltagare med incidens av kardiovaskulär (CV) död, hjärtinfarkt (MI) eller stroke under 30 dagar från första laddningsdos (LD)
Tidsram: Första LD till 30 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en CV-död, MI eller stroke dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första LD till 30 dagar efter första LD
Andel deltagare med incidens av kardiovaskulär (CV) död eller hjärtinfarkt (MI) under 30 dagar från första laddningsdos (LD)
Tidsram: Första LD till 30 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en CV-död eller MI dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första LD till 30 dagar efter första LD
Andel deltagare med incidens av kardiovaskulär (CV) död, hjärtinfarkt (MI) eller akut revaskularisering (UR) under 30 dagar från första laddningsdos (LD)
Tidsram: Första LD till 30 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en CV-död, MI eller UR dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första LD till 30 dagar efter första LD
Andel deltagare med incidens av kardiovaskulär (CV) död under 30 dagar från första laddningsdos (LD)
Tidsram: Första LD till 30 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en CV-död delat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första LD till 30 dagar efter första LD
Andel deltagare med incidens av bestämd eller sannolik stenttrombos (ST) enligt kriterierna för Academic Research Consortium (ARC) under 30 dagar från första laddningsdos (LD)
Tidsram: Första LD till 30 dagar efter första LD
ARC-kriterier användes för att definiera ST. Definitiv ST är angiografisk eller patologisk bekräftelse på partiell eller total trombotisk ocklusion inom peri-stentregionen, och minst ett av följande ytterligare kriterier: akuta ischemiska symtom; ischemiska elektrokardiogramförändringar; förhöjda hjärtbiomarkörer. Sannolik ST är varje oförklarat dödsfall inom 30 dagar efter stentimplantation; varje hjärtinfarkt, som är relaterat till dokumenterad akut ischemi i den implanterade stentens territorium utan angiografisk bekräftelse av ST och i frånvaro av någon annan uppenbar orsak. Andelen deltagare är det totala antalet deltagare som upplever en bestämd eller trolig stenttrombos dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första LD till 30 dagar efter första LD
Andel deltagare med dödsfall av alla orsaker, hjärtinfarkt (MI), stroke eller bypassgraft för hela kranskärlen (CABG) och icke-CABG trombolys vid hjärtinfarkt (TIMI) större blödningar under 30 dagar från första laddningsdos (LD)
Tidsram: Första LD till 30 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en dödsfall av alla orsaker, MI, stroke eller CABG och icke-CABG TIMI större blödning dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första LD till 30 dagar efter första LD
Förändring i standardiserat troponin från baslinje till perkutan koronarintervention (PCI)
Tidsram: Baslinje, före PCI (inte mer än 48 timmar efter randomisering)
Standardiserat troponin definieras som förhållandet mellan det analyserade troponinvärdet dividerat med den övre normalgränsen (ULN). Medelvärden för minsta kvadrater (LS) erhölls från en analys av kovariansmodell (ANCOVA) med behandling som en fixerad effekt och baslinjestandardiserat troponin som en kovariat.
Baslinje, före PCI (inte mer än 48 timmar efter randomisering)
Procentandel av deltagare med incidens av all kransartär bypassgraft (CABG) eller icke-CABG trombolys vid hjärtinfarkt (TIMI) större blödning
Tidsram: Första laddningsdosen (LD) till och med 7 dagar efter första LD
Andelen deltagare är det totala antalet deltagare som upplever en CABG eller icke-CABG TIMI större blödning dividerat med antalet deltagare i behandlingsarmen multiplicerat med 100. Endpoint-händelser bedömdes av Clinical Endpoint Committee.
Första laddningsdosen (LD) till och med 7 dagar efter första LD

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sammanfattning av All-Cause Death
Tidsram: Randomisering genom 30 dagar
Alla dödsfall, oavsett eventuellt samband, bedömdes av Clinical Endpoint Committee (CEC) och rapporteras i denna tabell.
Randomisering genom 30 dagar

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eli Lilly and Company

Samarbetspartners

Daiichi Sankyo Co., Ltd.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2009

Primärt slutförande (Faktisk)

1 januari 2013

Avslutad studie (Faktisk)

1 februari 2013

Studieregistreringsdatum

Först inskickad

17 november 2009

Först inskickad som uppfyllde QC-kriterierna

17 november 2009

Första postat (Uppskatta)

18 november 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 februari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 januari 2014

Senast verifierad

1 januari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 12918
  • H7T-MC-TADF (Annan identifierare: Eli Lilly and Company)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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