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Non-ST 상승 심근경색의 PCI 또는 진단 시 Prasugrel의 비교 (ACCOAST)

2014년 1월 17일 업데이트: Eli Lilly and Company

경피적 관상동맥 중재술(PCI) 시 프라수그렐 또는 비 ST-상승 심근경색증(NSTEMI) 환자의 진단 시 전치료제 비교: ACCOAST 연구

이 임상시험의 목적은 관상동맥 조영술/경피적 관상동맥 중재술(PCI)이 예정된 상승된 트로포닌이 있는 비 ST 상승 심근경색증(NSTEMI) 참가자에서 프라수그렐로 전처리하는 것과 관련된 잠재적 이점/위험성을 조사하는 것입니다.

연구 개요

상세 설명

이 시험은 두 개의 부문으로 구성됩니다. 한 팔은 비 전처리 팔입니다. 이 부문의 참가자는 NSTEMI 진단 직후와 진단 관상 동맥 조영술 전에 위약을 투여받습니다. 60 mg prasugrel loading dose는 PCI 진행 시 관상동맥 조영술 직후에 주어질 것입니다. 그 후, 참가자들은 30일까지 프라수그렐의 일일 유지 용량을 받게 됩니다. 75세 이상이거나 체중이 60kg 미만인 참가자는 매일 5mg의 경구 투여량을 받습니다. 다른 모든 사람들은 30일 동안 10mg의 경구 일일 유지 용량을 받게 됩니다.

다른 부문은 참가자가 NSTEMI 진단 직후 및 진단 관상 동맥 조영술 전에 투여되는 30mg의 프라수그렐로 분할 부하 용량 요법을 받는 전처리 부문입니다. 부하 용량(30mg)의 나머지는 참가자가 PCI를 진행할 때 투여됩니다. 그 후, 참가자들은 30일까지 프라수그렐의 일일 유지 용량을 받게 됩니다. 75세 이상이거나 체중이 60kg 미만인 참가자는 매일 5mg의 경구 투여량을 받습니다. 다른 모든 사람들은 30일 동안 10mg의 경구 일일 유지 용량을 받게 됩니다.

연구 유형

중재적

등록 (실제)

4033

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

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      • Olomouc, 체코 공화국, 775 20
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      • Plzen, 체코 공화국, 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, 체코 공화국, 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, 체코 공화국, 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.
      • Adana, 칠면조, 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, 칠면조, 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, 칠면조, 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, 칠면조, 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, 칠면조, 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, 칠면조, 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, 칠면조, 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, 칠면조, 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, 칠면조, 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.
    • Alberta
      • Calgary, Alberta, 캐나다, 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, 캐나다, Vancouver
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ontario
      • Toronto, Ontario, 캐나다, M5B 1W8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Quebec
      • Montreal, Quebec, 캐나다, H4J 1C5
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sainte-Foy, Quebec, 캐나다, G1V 4G5
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다, S7N 0W8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Braga, 포르투갈, 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, 포르투갈, 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, 포르투갈, 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, 포르투갈, 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.
      • Belchatow, 폴란드, 97-400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chrzanow, 폴란드, 32-500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Grodzisk Mazowiecki, 폴란드, 05-825
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Katowice, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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, 폴란드, 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.
      • Bastia, 프랑스, 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, 프랑스, 69500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Caluire Et Cuire, 프랑스, 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, 프랑스, 06401
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chateauroux, 프랑스, 36019
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Corbeil Essonnes, 프랑스, 91106
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lagny Sur Marne, 프랑스, 77405
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Le Coudray, 프랑스, 28630
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lille, 프랑스, 59037
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lyon, 프랑스, 69317
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Marseille, 프랑스, 13015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Metz, 프랑스, 57085
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Metz Tessy, 프랑스, 74370
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Montauban, 프랑스, 82017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Montreuil, 프랑스, 93105
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nimes, 프랑스, 30029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Paris, 프랑스, 75743
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pau Cedex, 프랑스, 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, 프랑스, 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, 프랑스, 35033
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toulouse, 프랑스, 31076
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valence, 프랑스, 26953
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vannes, 프랑스, 56017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vienne, 프랑스, 38209
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Villeurbanne, 프랑스, 69100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Turku, 핀란드, 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.
      • Balatonfured, 헝가리, 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, 헝가리, 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, 헝가리, 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, 헝가리, 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.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

포함 기준:

  • 상승된 트로포닌과 함께 비 ST분절 상승으로 구성된 급성 관상 동맥 증후군이 있음
  • 계획된 무작위화 시점으로부터 2시간 이상 24시간 이내, 그러나 무작위화 시점으로부터 48시간 이내의 관상동맥 조영술/PCI 예정
  • 각각의 라벨에 따라 프라수그렐, 아스피린(ASA) 및 당단백질 IIb/IIIa 수용체(GPIIb/IIIa) 억제제로 치료할 수 있어야 합니다.
  • 클로피도그렐 75mg의 유지 용량을 복용 중일 수 있으며 프라수그렐로 전환할 수 있어야 합니다.
  • 심장 도관 검사실 병원 또는 심장 도관 검사실 병원 부속 병원/구급차 서비스에 등록해야 함

제외 기준:

  • 진입 또는 무작위 배정 시 ST분절 상승 심근경색증(STEMI)이 있음
  • 심인성 쇼크가 있다
  • 난치성 심실성 부정맥이 있는 경우
  • 뉴욕 심장 협회(NYHA) 클래스 IV 울혈성 심부전(CHF)이 있는 경우
  • 연구 참여 또는 무작위 배정 후 1주 이내에 심정지가 발생한 경우

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 무전처리
진단 시 위약 경구 부하 용량을 투여하고 PCI 시점에 프라수그렐 60mg 경구 부하 용량을 투여한 후 30일 동안 프라수그렐 5mg 또는 10mg 경구 일일 유지 용량을 투여합니다.
구두로 관리
다른 이름들:
  • 효율적
  • LY640315
  • CS-747
  • 효율적인
구두로 한 번 관리
실험적: 분할 선량
진단 시 프라수그렐 30mg 경구 부하 용량을 투여하고 PCI 시점에 프라수그렐 30mg 경구 용량을 투여한 후 30일 동안 프라수그렐 5mg 또는 10mg 경구 일일 유지 용량을 투여합니다.
구두로 관리
다른 이름들:
  • 효율적
  • LY640315
  • CS-747
  • 효율적인

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
심혈관(CV) 사망, 심근경색(MI), 뇌졸중, 긴급 혈관재생술(UR) 또는 당단백질(GP) IIb/IIIa 억제제 구제금융이 발생한 참가자의 비율
기간: 첫 번째 로딩 용량(LD)부터 첫 번째 LD 후 7일까지
참가자 비율은 CV 사망, MI, 뇌졸중, UR 또는 GPIIb/IIIa 억제제 구제금융을 경험한 참가자의 총 수를 치료군의 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 로딩 용량(LD)부터 첫 번째 LD 후 7일까지

2차 결과 측정

결과 측정
측정값 설명
기간
심근경색(TIMI) 주요 출혈에서 모든 원인 사망, 심근경색(MI), 뇌졸중 또는 모든 관상동맥우회술(CABG) 및 비 CABG 혈전용해증이 있는 참가자의 비율
기간: 첫 번째 로딩 용량(LD)부터 첫 번째 LD 후 7일까지
참가자 비율은 모든 원인으로 인한 사망, MI, 뇌졸중 또는 CABG 및 비 CABG TIMI 주요 출혈을 경험한 참가자의 총 수를 치료군의 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 로딩 용량(LD)부터 첫 번째 LD 후 7일까지
심혈관(CV) 사망, 심근경색(MI) 또는 뇌졸중 발생률이 첫 번째 부하 용량(LD)으로부터 30일 동안 발생한 참가자의 비율
기간: 첫 번째 LD부터 첫 번째 LD 이후 30일까지
참가자 비율은 CV 사망, MI 또는 뇌졸중을 경험한 총 참가자 수를 치료군 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 LD부터 첫 번째 LD 이후 30일까지
심혈관(CV) 사망 또는 심근경색(MI)의 발생률이 첫 번째 로딩 용량(LD)으로부터 30일 동안 발생한 참가자의 비율
기간: 첫 번째 LD부터 첫 번째 LD 이후 30일까지
참가자 비율은 CV 사망 또는 MI를 경험한 총 참가자 수를 치료군 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 LD부터 첫 번째 LD 이후 30일까지
심혈관(CV) 사망, 심근경색(MI) 또는 긴급 혈관재생술(UR) 발생률이 첫 번째 부하 용량(LD)으로부터 30일 동안 발생한 참가자의 비율
기간: 첫 번째 LD부터 첫 번째 LD 이후 30일까지
참가자의 백분율은 CV 사망, MI 또는 UR을 경험한 참가자의 총 수를 치료군의 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 LD부터 첫 번째 LD 이후 30일까지
첫 번째 부하 용량(LD)으로부터 30일 동안 심혈관(CV) 사망 발생률이 있는 참가자의 비율
기간: 첫 번째 LD부터 첫 번째 LD 이후 30일까지
참가자 비율은 CV 사망을 경험한 총 참가자 수를 치료군 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 LD부터 첫 번째 LD 이후 30일까지
ARC(Academic Research Consortium) 기준에 따라 첫 번째 로딩 용량(LD)으로부터 30일 동안 확실하거나 가능성 있는 스텐트 혈전증(ST) 발생률이 있는 참가자의 비율
기간: 첫 번째 LD부터 첫 번째 LD 이후 30일까지
ARC 기준은 ST를 정의하는 데 사용되었습니다. 명확한 ST는 스텐트 주위 영역 내에서 부분적 또는 전체 혈전성 폐색의 혈관조영학적 또는 병리학적 확인이며, 다음 추가 기준 중 적어도 하나입니다: 급성 허혈 증상; 허혈성 심전도 변화; 상승된 심장 바이오마커. 가능한 ST는 스텐트 이식 후 30일 이내에 설명할 수 없는 모든 사망입니다. ST의 혈관조영학적 확인 없이 이식된 스텐트 영역의 문서화된 급성 허혈과 관련이 있고 다른 명백한 원인이 없는 모든 MI. 참가자 비율은 스텐트 혈전증이 확실하거나 가능성이 있는 참가자의 총 수를 치료군의 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 LD부터 첫 번째 LD 이후 30일까지
모든 원인으로 인한 사망, 심근경색(MI), 뇌졸중 또는 모든 관상동맥우회술(CABG) 및 비CABG 비CABG 혈전용해증(TIMI) 주요 출혈이 첫 번째 부하 용량(LD)으로부터 30일 동안 발생한 참가자의 비율
기간: 첫 번째 LD부터 첫 번째 LD 이후 30일까지
참가자 비율은 모든 원인으로 인한 사망, MI, 뇌졸중 또는 CABG 및 비 CABG TIMI 주요 출혈을 경험한 참가자의 총 수를 치료군의 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 LD부터 첫 번째 LD 이후 30일까지
기준선에서 경피적 관상동맥 중재술(PCI)로 표준화된 트로포닌의 변화
기간: 기준선, PCI 이전(무작위화 후 48시간 이내)
표준화된 트로포닌은 분석된 트로포닌 값을 정상 상한치(ULN)로 나눈 비율로 정의됩니다. 최소 제곱(LS) 평균은 고정 효과로 처리하고 공변량으로 기준선 표준화 트로포닌을 사용하는 공분산 분석(ANCOVA) 모델에서 얻었습니다.
기준선, PCI 이전(무작위화 후 48시간 이내)
심근경색증(TIMI) 주요 출혈에서 모든 관상동맥 우회술 이식(CABG) 또는 비CABG 혈전용해증 발생률이 있는 참가자 비율
기간: 첫 번째 로딩 용량(LD)부터 첫 번째 LD 후 7일까지
참가자 비율은 CABG 또는 비 CABG TIMI 주요 출혈을 경험한 총 참가자 수를 치료군 참가자 수로 나눈 값에 100을 곱한 값입니다. 종점 사건은 임상 종점 위원회에 의해 판정되었습니다.
첫 번째 로딩 용량(LD)부터 첫 번째 LD 후 7일까지

기타 결과 측정

결과 측정
측정값 설명
기간
모든 원인에 의한 사망 요약
기간: 30일 동안 무작위 배정
관련 가능성에 관계없이 모든 사망은 CEC(Clinical Endpoint Committee)에서 판정했으며 이 표에 보고됩니다.
30일 동안 무작위 배정

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연구 기록 날짜

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연구 주요 날짜

연구 시작

2009년 12월 1일

기본 완료 (실제)

2013년 1월 1일

연구 완료 (실제)

2013년 2월 1일

연구 등록 날짜

최초 제출

2009년 11월 17일

QC 기준을 충족하는 최초 제출

2009년 11월 17일

처음 게시됨 (추정)

2009년 11월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 2월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 1월 17일

마지막으로 확인됨

2014년 1월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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프라수그렐에 대한 임상 시험

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