- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01015287
Сравнение прасугрела при ЧКВ или время диагностики инфаркта миокарда без подъема сегмента ST (ACCOAST)
Сравнение прасугрела во время чрескожного коронарного вмешательства (ЧКВ) или в качестве предварительного лечения во время диагностики у пациентов с инфарктом миокарда без подъема сегмента ST (NSTEMI): исследование ACCOAST
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Это испытание состоит из двух рук. Одна рука не подвергалась предварительной обработке. Участники этой группы получат плацебо сразу после постановки диагноза NSTEMI и перед диагностической коронарной ангиографией. Нагрузочная доза прасугрела 60 мг вводится сразу после коронарографии при переходе к ЧКВ. Впоследствии участники будут получать ежедневные поддерживающие дозы прасугрела до 30-го дня. Участники, которые старше или равны 75 годам или имеют массу тела менее 60 килограммов (кг), будут получать пероральную дозу 5 мг в день. Все остальные будут получать пероральную поддерживающую дозу 10 мг ежедневно в течение 30 дней.
Другая группа представляет собой группу предварительного лечения, в которой участники будут получать разделенную нагрузочную дозу с 30 мг прасугрела, вводимого сразу после постановки диагноза NSTEMI и перед диагностической коронарной ангиографией. Оставшаяся часть нагрузочной дозы (30 мг) будет вводиться, когда участники переходят к ЧКВ. Впоследствии участники будут получать ежедневные поддерживающие дозы прасугрела до 30-го дня. Участники, которые старше или равны 75 годам или имеют массу тела менее 60 кг, будут получать пероральную дозу 5 мг в день. Все остальные будут получать пероральную поддерживающую дозу 10 мг ежедневно в течение 30 дней.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Braunau Am Inn, Австрия, 5280
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Graz, Австрия, 8020
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Linz, Австрия, 4020
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Vienna, Австрия, A1090
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Bonheiden, Бельгия, 2820
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Brugge, Бельгия, 8000
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Charleroi, Бельгия, 6000
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Genk, Бельгия, 3600
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Leuven, Бельгия, 3000
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Yvoir, Бельгия, 5530
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Balatonfured, Венгрия, 8230
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Budapest, Венгрия, 1096
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Pecs, Венгрия, 7624
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Zalaegerszeg, Венгрия, 8900
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Bad Nauheim, Германия, 61231
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Bad Segeberg, Германия, 23795
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Bochum, Германия, 44791
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Bonn, Германия, 53105
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Coburg, Германия, 96450
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Dachau, Германия, 85221
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Eutin, Германия, 23701
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Frankfurt, Германия, 60596
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Halle, Германия, 06120
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Hamburg, Германия, 20099
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Hannover, Германия, 30625
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Heidelberg, Германия, D-69120
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Jena, Германия, 07740
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Kassel, Германия, 34125
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Leipzig, Германия, 04289
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Ludwigshafen, Германия, 67063
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Mainz, Германия, 55101
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Munich, Германия, 80336
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Rastatt, Германия, 76437
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Rostock, Германия, 18057
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Villingen-Schwenningen, Германия, 78050
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Beer Yaakov, Израиль, 70300
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Haifa, Израиль, 34362
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Jerusalem, Израиль, 91120
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Kfar Saba, Израиль, 44281
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Nahariya, Израиль, 22100
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Tel-Aviv, Израиль, 64239
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Tiberias, Израиль, 15208
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Arezzo, Италия, 52100
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Chieti, Италия, 66013
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Grosseto, Италия, 58100
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Legnano, Италия, 20025
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Lucca, Италия
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Massa, Италия, 54100
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Monza, Италия, 20900
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Napoli, Италия, 80100
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Pavia, Италия, 27100
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Perugia, Италия, 06156
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Pisa, Италия, 56100
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Prato, Италия, 50047
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Reggio Emilia, Италия, 42100
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Rome, Италия, 00100
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Torino, Италия, 10100
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Udine, Италия, 33100
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Venezia, Италия, 30035
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Alberta
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Calgary, Alberta, Канада, T2N 2T9
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British Columbia
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Vancouver, British Columbia, Канада, Vancouver
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Ontario
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Toronto, Ontario, Канада, M5B 1W8
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Quebec
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Montreal, Quebec, Канада, H4J 1C5
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Sainte-Foy, Quebec, Канада, G1V 4G5
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Saskatchewan
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Saskatoon, Saskatchewan, Канада, S7N 0W8
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Liepaja, Латвия, 3414
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Riga, Латвия, 1038
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Kaunas, Литва, LT-50009
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Klaipedos, Литва, 92288
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Vilnius, Литва, LT-08661
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Amsterdam, Нидерланды, 1081 HV
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Eindhoven, Нидерланды, 5623 EJ
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Leeuwarden, Нидерланды, 8934 AD
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Nieuwegein, Нидерланды, 3435 CM
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Nijmegen, Нидерланды, 6500 HB
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Tiel, Нидерланды, 4002 WP
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Zwolle, Нидерланды, 8025 AB
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Belchatow, Польша, 97-400
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Chrzanow, Польша, 32-500
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Grodzisk Mazowiecki, Польша, 05-825
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Katowice, Польша, 40-635
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Klodzko, Польша, 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.
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Krakow, Польша, 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.
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Lodz, Польша, 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.
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Lublin, Польша, 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.
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Mielec, Польша, 39-300
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Naleczow, Польша, 24-140
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Nowy Sacz, Польша, 33-300
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Nowy Targ, Польша, 34-400
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Nysa, Польша, 48-300
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Ostrowiec Swietokrzyski, Польша, 27-400
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Oswiecim, Польша, 32-600
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Polanica-Zdroj, Польша, 57-320
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Pulawy, Польша, 24-100
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Radom, Польша, 26-617
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Sanok, Польша, 38-500
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Stalowa Wola, Польша, 37-450
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Starogard Gdanski, Польша, 82-200
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Tarnow, Польша, 33-100
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Warsaw, Польша, 04-628
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Wejherowo, Польша, 84-200
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Wroclaw, Польша, 53-114
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Braga, Португалия, 4710-243
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Carnaxide, Португалия, 2794-006
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Faro, Португалия, 8000-386
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Leiria, Португалия, 2410-197
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Bucharest, Румыния, 050098
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Targu Mures, Румыния, 540136
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Banska Bystrica, Словакия, 97401
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Kosice, Словакия, 04011
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Nitra, Словакия, 94901
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Adana, Турция, 1330
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Ankara, Турция, 06520
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Antalya, Турция, 07070
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Fatih, Турция, 34300
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Isparta, Турция, 32100
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Istanbul, Турция, 34303
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Kayseri, Турция, 38039
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Kocaeli, Турция, 41900
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Sisli, Турция, 34381
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Turku, Финляндия, 20521
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Bastia, Франция, 20600
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Bron, Франция, 69500
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Caluire Et Cuire, Франция, 69300
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Cannes Cedex, Франция, 06401
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Chateauroux, Франция, 36019
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Corbeil Essonnes, Франция, 91106
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Lagny Sur Marne, Франция, 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.
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Le Coudray, Франция, 28630
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Lille, Франция, 59037
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Lyon, Франция, 69317
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Marseille, Франция, 13015
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Metz, Франция, 57085
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Metz Tessy, Франция, 74370
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Montauban, Франция, 82017
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Montreuil, Франция, 93105
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Nimes, Франция, 30029
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Paris, Франция, 75743
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Pau Cedex, Франция, 64046
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Pierre Benite, Франция, 69495
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Rennes, Франция, 35033
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Toulouse, Франция, 31076
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Valence, Франция, 26953
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Vannes, Франция, 56017
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Vienne, Франция, 38209
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Villeurbanne, Франция, 69100
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Brno, Чешская Республика, 625 00
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Hradec Kralove, Чешская Республика, 500 05
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Olomouc, Чешская Республика, 775 20
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Plzen, Чешская Республика, 30460
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Prague, Чешская Республика, 169 02
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Usti Nad Labem, Чешская Республика, 40113
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Goteborg, Швеция, 413 45
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Критерии включения:
- Имеют острый коронарный синдром, состоящий из подъема сегмента ST без подъема тропонина.
- Запланировано коронарографию/ЧКВ больше или равно 2 и меньше 24 часов с момента запланированной рандомизации, но не более 48 часов с момента рандомизации
- Должен иметь право на лечение прасугрелом, аспирином (АСК) и ингибитором рецептора гликопротеина IIb/IIIa (GPIIb/IIIa) согласно соответствующим этикеткам.
- Может принимать поддерживающую дозу клопидогрела 75 мг и должен иметь возможность перейти на прасугрель
- Должен быть зарегистрирован в больнице с лабораторией катетеризации сердца или в больнице/службе скорой помощи, связанной с больницей с лабораторией катетеризации сердца.
Критерий исключения:
- Наличие инфаркта миокарда с подъемом сегмента ST (ИМпST) на момент включения или рандомизации
- Иметь кардиогенный шок
- Наличие рефрактерных желудочковых аритмий
- Имеют застойную сердечную недостаточность IV класса (ЗСН) Нью-Йоркской кардиологической ассоциации (NYHA)
- У вас была остановка сердца в течение 1 недели после включения или рандомизации в исследование
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Без предварительной обработки
Пероральная нагрузочная доза плацебо дается во время постановки диагноза, а пероральная нагрузочная доза 60 мг (мг) прасугрела дается во время ЧКВ с последующей пероральной поддерживающей дозой 5 мг или 10 мг перорально ежедневно в течение 30 дней.
|
Вводится перорально
Другие имена:
Вводят однократно перорально
|
|
Экспериментальный: Раздельная загрузочная доза
Пероральная нагрузочная доза прасугрела 30 мг вводится при постановке диагноза, а пероральная доза 30 мг прасугрела вводится во время ЧКВ с последующей пероральной поддерживающей дозой 5 мг или 10 мг перорально ежедневно в течение 30 дней.
|
Вводится перорально
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Процент участников с возникновением сердечно-сосудистой (CV) смерти, инфаркта миокарда (MI), инсульта, срочной реваскуляризации (UR) или экстренной помощи ингибитора гликопротеина (GP) IIb/IIIa
Временное ограничение: Первая нагрузочная доза (LD) через 7 дней после первой LD
|
Процент участников представляет собой общее количество участников, перенесших сердечно-сосудистую смерть, ИМ, инсульт, УР или спасение от ингибитора GPIIb/IIIa, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
|
Первая нагрузочная доза (LD) через 7 дней после первой LD
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Процент участников со смертью от всех причин, инфарктом миокарда (ИМ), инсультом или шунтированием всех коронарных артерий (АКШ) и тромболизисом без АКШ при инфаркте миокарда (TIMI) Большое кровотечение
Временное ограничение: Первая нагрузочная доза (LD) через 7 дней после первой LD
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Процент участников — это общее количество участников, перенесших смерть от всех причин, ИМ, инсульт или КШ и большое кровотечение по TIMI без КШ, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первая нагрузочная доза (LD) через 7 дней после первой LD
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Процент участников с сердечно-сосудистой (СС) смертью, инфарктом миокарда (ИМ) или инсультом в течение 30 дней после первой нагрузочной дозы (ЛД)
Временное ограничение: Первый LD через 30 дней после первого LD
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Процент участников — это общее количество участников, перенесших сердечно-сосудистую смерть, ИМ или инсульт, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первый LD через 30 дней после первого LD
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Процент участников с сердечно-сосудистой (СС) смертью или инфарктом миокарда (ИМ) в течение 30 дней после первой нагрузочной дозы (ЛД)
Временное ограничение: Первый LD через 30 дней после первого LD
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Процент участников — это общее количество участников, перенесших сердечно-сосудистую смерть или ИМ, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первый LD через 30 дней после первого LD
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Процент участников с сердечно-сосудистой (СС) смертью, инфарктом миокарда (ИМ) или срочной реваскуляризацией (УР) в течение 30 дней после первой нагрузочной дозы (ЛД)
Временное ограничение: Первый LD через 30 дней после первого LD
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Процент участников — это общее количество участников, перенесших сердечно-сосудистую смерть, ИМ или УР, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первый LD через 30 дней после первого LD
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Процент участников с сердечно-сосудистой (СС) смертью в течение 30 дней после первой нагрузочной дозы (ЛД)
Временное ограничение: Первый LD через 30 дней после первого LD
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Процент участников представляет собой общее количество участников, перенесших сердечно-сосудистую смерть, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первый LD через 30 дней после первого LD
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Процент участников с возникновением определенного или вероятного тромбоза стента (ST) в соответствии с критериями Консорциума академических исследований (ARC) в течение 30 дней после первой нагрузочной дозы (LD)
Временное ограничение: Первый LD через 30 дней после первого LD
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Критерии ARC использовались для определения ST.
Определенный ST является ангиографическим или патологическим подтверждением частичной или полной тромботической окклюзии в области вокруг стента и по крайней мере одним из следующих дополнительных критериев: симптомы острой ишемии; ишемические изменения электрокардиограммы; повышенные сердечные биомаркеры.
Вероятный ST — любая необъяснимая смерть в течение 30 дней после имплантации стента; любой ИМ, связанный с документально подтвержденной острой ишемией в области имплантированного стента без ангиографического подтверждения ST и при отсутствии какой-либо другой очевидной причины.
Процент участников — это общее число участников с определенным или вероятным тромбозом стента, деленное на число участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первый LD через 30 дней после первого LD
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Процент участников со смертью от всех причин, инфарктом миокарда (ИМ), инсультом или аортокоронарным шунтированием (АКШ) и тромболизисом без АКШ при инфаркте миокарда (TIMI) Большое кровотечение в течение 30 дней после первой нагрузочной дозы (ЛД)
Временное ограничение: Первый LD через 30 дней после первого LD
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Процент участников — это общее количество участников, перенесших смерть от всех причин, ИМ, инсульт или КШ и большое кровотечение по TIMI без КШ, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первый LD через 30 дней после первого LD
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Изменение стандартизированного тропонина по сравнению с исходным уровнем до чрескожного коронарного вмешательства (ЧКВ)
Временное ограничение: Исходный уровень, до ЧКВ (не более 48 часов после рандомизации)
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Стандартизированный тропонин определяется как отношение измеренного значения тропонина к верхней границе нормы (ВГН).
Средние значения метода наименьших квадратов (LS) были получены из модели анализа ковариации (ANCOVA) с лечением в качестве фиксированного эффекта и базовым стандартизированным тропонином в качестве ковариации.
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Исходный уровень, до ЧКВ (не более 48 часов после рандомизации)
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Процент участников с частотой возникновения массивного кровотечения при аортокоронарном шунтировании (АКШ) или тромболизисе без АКШ при инфаркте миокарда (TIMI)
Временное ограничение: Первая нагрузочная доза (LD) через 7 дней после первой LD
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Процент участников — это общее количество участников, перенесших большое кровотечение по TIMI после АКШ или не АКШ, деленное на количество участников в группе лечения, умноженное на 100.
События конечной точки оценивались Комитетом по клиническим конечным точкам.
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Первая нагрузочная доза (LD) через 7 дней после первой LD
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Краткое изложение смерти от всех причин
Временное ограничение: Рандомизация через 30 дней
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Все случаи смерти, независимо от возможного родства, были рассмотрены Комитетом по клиническим конечным точкам (CEC) и представлены в этой таблице.
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Рандомизация через 30 дней
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Соавторы и исследователи
Спонсор
Соавторы
Публикации и полезные ссылки
Общие публикации
- Silvain J, Rakowski T, Lattuca B, Liu Z, Bolognese L, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Miller D, Portal JJ, Collet JP, Vicaut E, Montalescot G, Dudek D; ACCOAST Investigators. Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Mar 5;73(8):906-914. doi: 10.1016/j.jacc.2018.11.055.
- Porto I, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Le Gall N, Zagar AJ, LeNarz LA, Miller D, Montalescot G; ACCOAST Investigators. Impact of Access Site on Bleeding and Ischemic Events in Patients With Non-ST-Segment Elevation Myocardial Infarction Treated With Prasugrel: The ACCOAST Access Substudy. JACC Cardiovasc Interv. 2016 May 9;9(9):897-907. doi: 10.1016/j.jcin.2016.01.041.
- Dudek D, Dziewierz A, Widimsky P, Bolognese L, Goldstein P, Hamm C, Tanguay JF, LeNarz L, Miller DL, Brown E, Ten Berg J, Montalescot G; ACCOAST Investigators. Impact of prasugrel pretreatment and timing of coronary artery bypass grafting on clinical outcomes of patients with non-ST-segment elevation myocardial infarction: From the A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST-Elevation Myocardial Infarction (ACCOAST) study. Am Heart J. 2015 Nov;170(5):1025-1032.e2. doi: 10.1016/j.ahj.2015.07.017. Epub 2015 Jul 26.
- Widimsky P, Motovska Z, Bolognese L, Dudek D, Hamm C, Tanguay JF, Ten Berg J, Brown E, LeNarz L, Miller DL, Montalescot G; ACCOAST Investigators. Predictors of bleeding in patients with acute coronary syndromes treated with prasugrel. Heart. 2015 Aug;101(15):1219-24. doi: 10.1136/heartjnl-2015-307686. Epub 2015 Jun 9.
- Montalescot G, Collet JP, Ecollan P, Bolognese L, Ten Berg J, Dudek D, Hamm C, Widimsky P, Tanguay JF, Goldstein P, Brown E, Miller DL, LeNarz L, Vicaut E; ACCOAST Investigators. Effect of prasugrel pre-treatment strategy in patients undergoing percutaneous coronary intervention for NSTEMI: the ACCOAST-PCI study. J Am Coll Cardiol. 2014 Dec 23;64(24):2563-2571. doi: 10.1016/j.jacc.2014.08.053.
- Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg JM, Miller DL, Costigan TM, Goedicke J, Silvain J, Angioli P, Legutko J, Niethammer M, Motovska Z, Jakubowski JA, Cayla G, Visconti LO, Vicaut E, Widimsky P; ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med. 2013 Sep 12;369(11):999-1010. doi: 10.1056/NEJMoa1308075. Epub 2013 Sep 1.
- Montalescot G, Bolognese L, Dudek D, Goldstein P, Hamm C, Tanguay JF, ten Berg J, Widimsky P, Luo J, Miller DL, Goedicke J. A comparison of prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis in patients with non-ST-segment elevation myocardial infarction: design and rationale for the ACCOAST study. Am Heart J. 2011 Apr;161(4):650-656.e1. doi: 10.1016/j.ahj.2010.10.017. Epub 2011 Feb 25.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 12918
- H7T-MC-TADF (Другой идентификатор: Eli Lilly and Company)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .