Uma Comparação de Prasugrel em ICP ou Momento do Diagnóstico de Infarto do Miocárdio Sem Elevação do ST (ACCOAST)
17 de janeiro de 2014 atualizado por: Eli Lilly and Company
Uma comparação de prasugrel no momento da intervenção coronária percutânea (ICP) ou como pré-tratamento no momento do diagnóstico em pacientes com infarto do miocárdio sem elevação do segmento ST (NSTEMI): o estudo ACCOAST
O objetivo deste estudo é investigar os benefícios/riscos potenciais em relação ao pré-tratamento com prasugrel em participantes com infarto do miocárdio sem elevação do segmento ST (NSTEMI) com troponina elevada agendada para angiografia coronária/intervenção coronária percutânea (ICP).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Este ensaio consiste em dois braços. Um braço é um braço sem pré-tratamento. Os participantes neste braço receberão placebo imediatamente após o diagnóstico de NSTEMI e antes da angiografia coronária diagnóstica. Uma dose de ataque de 60 mg de prasugrel será administrada imediatamente após a angiografia coronária ao proceder à ICP. Posteriormente, os participantes receberão doses diárias de manutenção de prasugrel até o dia 30. Os participantes com idade igual ou superior a 75 anos ou com peso corporal inferior a 60 quilogramas (kg) receberão uma dose oral de 5 mg diariamente. Todos os outros receberão uma dose oral diária de manutenção de 10 mg por 30 dias.
O outro braço é um braço de pré-tratamento, no qual os participantes receberão um regime de dose de carga dividida com 30 mg de prasugrel administrado imediatamente após o diagnóstico de NSTEMI e antes da angiografia coronária diagnóstica. O restante da dose de ataque (30 mg) será administrado quando os participantes estiverem procedendo à ICP. Posteriormente, os participantes receberão doses diárias de manutenção de prasugrel até o dia 30. Os participantes com idade igual ou superior a 75 anos ou com peso corporal inferior a 60 kg receberão uma dose oral de 5 mg diariamente. Todos os outros receberão uma dose oral diária de manutenção de 10 mg por 30 dias.
Tipo de estudo
Intervencional
Inscrição (Real)
4033
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bad Nauheim, Alemanha, 61231
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Bad Segeberg, Alemanha, 23795
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Bochum, Alemanha, 44791
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Bonn, Alemanha, 53105
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Coburg, Alemanha, 96450
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Dachau, Alemanha, 85221
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Eutin, Alemanha, 23701
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Frankfurt, Alemanha, 60596
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Halle, Alemanha, 06120
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Hamburg, Alemanha, 20099
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Hannover, Alemanha, 30625
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Heidelberg, Alemanha, D-69120
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Jena, Alemanha, 07740
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Kassel, Alemanha, 34125
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Leipzig, Alemanha, 04289
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Ludwigshafen, Alemanha, 67063
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Mainz, Alemanha, 55101
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Munich, Alemanha, 80336
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Rastatt, Alemanha, 76437
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Rostock, Alemanha, 18057
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Villingen-Schwenningen, Alemanha, 78050
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Bonheiden, Bélgica, 2820
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Brugge, Bélgica, 8000
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Charleroi, Bélgica, 6000
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Genk, Bélgica, 3600
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Leuven, Bélgica, 3000
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Yvoir, Bélgica, 5530
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Alberta
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Calgary, Alberta, Canadá, T2N 2T9
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British Columbia
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Vancouver, British Columbia, Canadá, Vancouver
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Ontario
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Toronto, Ontario, Canadá, M5B 1W8
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Quebec
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Montreal, Quebec, Canadá, H4J 1C5
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Sainte-Foy, Quebec, Canadá, G1V 4G5
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7N 0W8
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Banska Bystrica, Eslováquia, 97401
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Kosice, Eslováquia, 04011
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Nitra, Eslováquia, 94901
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Turku, Finlândia, 20521
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Bastia, França, 20600
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Bron, França, 69500
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Caluire Et Cuire, França, 69300
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Cannes Cedex, França, 06401
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Chateauroux, França, 36019
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Corbeil Essonnes, França, 91106
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Lagny Sur Marne, França, 77405
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Le Coudray, França, 28630
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Lille, França, 59037
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Lyon, França, 69317
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Marseille, França, 13015
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Metz, França, 57085
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Metz Tessy, França, 74370
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Montauban, França, 82017
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Montreuil, França, 93105
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Nimes, França, 30029
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Paris, França, 75743
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Pau Cedex, França, 64046
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Pierre Benite, França, 69495
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Rennes, França, 35033
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Toulouse, França, 31076
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Valence, França, 26953
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Vannes, França, 56017
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Vienne, França, 38209
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Villeurbanne, França, 69100
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Amsterdam, Holanda, 1081 HV
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Eindhoven, Holanda, 5623 EJ
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Leeuwarden, Holanda, 8934 AD
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Nieuwegein, Holanda, 3435 CM
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Nijmegen, Holanda, 6500 HB
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Tiel, Holanda, 4002 WP
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Zwolle, Holanda, 8025 AB
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Balatonfured, Hungria, 8230
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Budapest, Hungria, 1096
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Pecs, Hungria, 7624
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Zalaegerszeg, Hungria, 8900
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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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Arezzo, Itália, 52100
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Chieti, Itália, 66013
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Grosseto, Itália, 58100
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Legnano, Itália, 20025
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Lucca, Itália
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Massa, Itália, 54100
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Monza, Itália, 20900
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Napoli, Itália, 80100
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Pavia, Itália, 27100
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Perugia, Itália, 06156
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Pisa, Itália, 56100
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Prato, Itália, 50047
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Reggio Emilia, Itália, 42100
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Rome, Itália, 00100
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Torino, Itália, 10100
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Udine, Itália, 33100
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Venezia, Itália, 30035
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Liepaja, Letônia, 3414
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Riga, Letônia, 1038
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Kaunas, Lituânia, LT-50009
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Klaipedos, Lituânia, 92288
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Vilnius, Lituânia, LT-08661
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Adana, Peru, 1330
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Ankara, Peru, 06520
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Antalya, Peru, 07070
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Fatih, Peru, 34300
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Isparta, Peru, 32100
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Istanbul, Peru, 34303
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Kayseri, Peru, 38039
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Kocaeli, Peru, 41900
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Sisli, Peru, 34381
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Belchatow, Polônia, 97-400
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Chrzanow, Polônia, 32-500
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Grodzisk Mazowiecki, Polônia, 05-825
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Katowice, Polônia, 40-635
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Klodzko, Polônia, 57-300
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Krakow, Polônia, 31-501
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Lodz, Polônia, 91-347
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Lublin, Polônia, 20-954
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Mielec, Polônia, 39-300
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Naleczow, Polônia, 24-140
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Nowy Sacz, Polônia, 33-300
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Nowy Targ, Polônia, 34-400
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Nysa, Polônia, 48-300
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Ostrowiec Swietokrzyski, Polônia, 27-400
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Oswiecim, Polônia, 32-600
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Polanica-Zdroj, Polônia, 57-320
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Pulawy, Polônia, 24-100
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Radom, Polônia, 26-617
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Sanok, Polônia, 38-500
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Stalowa Wola, Polônia, 37-450
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Starogard Gdanski, Polônia, 82-200
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Tarnow, Polônia, 33-100
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Warsaw, Polônia, 04-628
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Wejherowo, Polônia, 84-200
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Wroclaw, Polônia, 53-114
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Braga, Portugal, 4710-243
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Carnaxide, Portugal, 2794-006
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Faro, Portugal, 8000-386
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Leiria, Portugal, 2410-197
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Brno, República Checa, 625 00
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Hradec Kralove, República Checa, 500 05
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Olomouc, República Checa, 775 20
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Plzen, República Checa, 30460
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Prague, República Checa, 169 02
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Usti Nad Labem, República Checa, 40113
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Bucharest, Romênia, 050098
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Targu Mures, Romênia, 540136
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Goteborg, Suécia, 413 45
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Braunau Am Inn, Áustria, 5280
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Graz, Áustria, 8020
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Linz, Áustria, 4020
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Vienna, Áustria, A1090
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Critério de inclusão:
- Tem síndrome coronariana aguda consistindo em não elevação do segmento ST com troponina elevada
- Agendado para angiografia coronária/ICP maior ou igual a 2 e menor que 24 horas a partir do momento da randomização planejada, mas não mais do que 48 horas a partir da randomização
- Deve ser elegível para tratamento com prasugrel, aspirina (AAS) e um inibidor do receptor de glicoproteína IIb/IIIa (GPIIb/IIIa) de acordo com os respectivos rótulos
- Pode estar em uma dose de manutenção de clopidogrel 75 mg e deve ser capaz de mudar para prasugrel
- Deve estar matriculado em um hospital-laboratório de cateterismo cardíaco ou em um hospital/serviço de ambulância afiliado a um hospital-laboratório de cateterismo cardíaco
Critério de exclusão:
- Presente com infarto do miocárdio com elevação do segmento ST (STEMI) no momento da entrada ou randomização
- Tem choque cardiogênico
- Têm arritmias ventriculares refratárias
- Ter insuficiência cardíaca congestiva (ICC) Classe IV da New York Heart Association (NYHA)
- Tiveram parada cardíaca dentro de 1 semana após a entrada ou randomização no estudo
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Sem pré-tratamento
Uma dose de ataque oral de placebo é administrada no momento do diagnóstico e uma dose de ataque oral de 60 miligramas (mg) de prasugrel é administrada no momento da ICP, seguida por 5 mg ou 10 mg de dose oral diária de manutenção de prasugrel por 30 dias.
|
Administrado por via oral
Outros nomes:
Administrado uma vez por via oral
|
|
Experimental: Dose de Carga Dividida
Uma dose oral de ataque de 30 mg de prasugrel é administrada no momento do diagnóstico e uma dose oral de 30 mg de prasugrel é administrada no momento da ICP, seguida por 5 mg ou 10 mg de dose oral diária de manutenção de prasugrel por 30 dias
|
Administrado por via oral
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
A porcentagem de participantes com ocorrência de morte cardiovascular (CV), infarto do miocárdio (IM), acidente vascular cerebral, revascularização urgente (UR) ou salvamento do inibidor de glicoproteína (GP) IIb/IIIa
Prazo: Primeira dose de ataque (LD) até 7 dias após a primeira LD
|
A porcentagem de participantes é o número total de participantes com morte CV, infarto do miocárdio, acidente vascular cerebral, UR ou salvamento do inibidor da GPIIb/IIIa dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
|
Primeira dose de ataque (LD) até 7 dias após a primeira LD
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Porcentagem de participantes com morte por todas as causas, infarto do miocárdio (IM), acidente vascular cerebral ou todos os enxertos de revascularização do miocárdio (CABG) e trombólise não CABG em infarto do miocárdio (TIMI) sangramento grave
Prazo: Primeira dose de ataque (LD) até 7 dias após a primeira LD
|
A porcentagem de participantes é o número total de participantes com morte por todas as causas, infarto do miocárdio, AVC ou CABG e sangramento maior não CABG TIMI dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
|
Primeira dose de ataque (LD) até 7 dias após a primeira LD
|
|
Porcentagem de participantes com incidência de morte cardiovascular (CV), infarto do miocárdio (IM) ou AVC durante 30 dias a partir da primeira dose de carga (LD)
Prazo: Primeiro LD até 30 dias após o primeiro LD
|
A porcentagem de participantes é o número total de participantes com morte CV, infarto do miocárdio ou AVC dividido pelo número de participantes no grupo de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
|
Primeiro LD até 30 dias após o primeiro LD
|
|
Porcentagem de participantes com incidência de morte cardiovascular (CV) ou infarto do miocárdio (IM) até 30 dias a partir da primeira dose de carga (LD)
Prazo: Primeiro LD até 30 dias após o primeiro LD
|
A porcentagem de participantes é o número total de participantes com morte CV ou infarto do miocárdio dividido pelo número de participantes no grupo de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
|
Primeiro LD até 30 dias após o primeiro LD
|
|
Porcentagem de participantes com incidência de morte cardiovascular (CV), infarto do miocárdio (IM) ou revascularização urgente (UR) até 30 dias após a primeira dose de ataque (LD)
Prazo: Primeiro LD até 30 dias após o primeiro LD
|
A porcentagem de participantes é o número total de participantes com morte CV, IM ou UR dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
|
Primeiro LD até 30 dias após o primeiro LD
|
|
Porcentagem de participantes com incidência de morte cardiovascular (CV) até 30 dias a partir da primeira dose de ataque (LD)
Prazo: Primeiro LD até 30 dias após o primeiro LD
|
A porcentagem de participantes é o número total de participantes com morte CV dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
|
Primeiro LD até 30 dias após o primeiro LD
|
|
Porcentagem de participantes com incidência de trombose de stent (ST) definitiva ou provável de acordo com os critérios do Academic Research Consortium (ARC) até 30 dias a partir da primeira dose de carga (LD)
Prazo: Primeiro LD até 30 dias após o primeiro LD
|
Critérios ARC foram usados para definir ST.
ST definido é a confirmação angiográfica ou patológica de oclusão trombótica parcial ou total na região peri-stent e pelo menos um dos seguintes critérios adicionais: sintomas isquêmicos agudos; alterações eletrocardiográficas isquêmicas; biomarcadores cardíacos elevados.
ST provável é qualquer morte inexplicável dentro de 30 dias após a implantação do stent; qualquer IM, que esteja relacionado com isquemia aguda documentada no território do stent implantado sem confirmação angiográfica de ST e na ausência de qualquer outra causa óbvia.
A porcentagem de participantes é o número total de participantes com trombose de stent definitiva ou provável dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
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Primeiro LD até 30 dias após o primeiro LD
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Porcentagem de participantes com morte por todas as causas, infarto do miocárdio (IM), AVC ou todos os enxertos de revascularização do miocárdio (CABG) e trombólise não CABG em infarto do miocárdio (TIMI) sangramento importante por 30 dias a partir da primeira dose de carga (LD)
Prazo: Primeiro LD até 30 dias após o primeiro LD
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A porcentagem de participantes é o número total de participantes com morte por todas as causas, infarto do miocárdio, AVC ou CABG e sangramento maior não CABG TIMI dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
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Primeiro LD até 30 dias após o primeiro LD
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Mudança na troponina padronizada da linha de base para a intervenção coronária percutânea (ICP)
Prazo: Linha de base, antes da ICP (não superior a 48 horas após a randomização)
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A troponina padronizada é definida como a razão entre o valor medido da troponina dividido pelo limite superior do normal (LSN).
As médias dos mínimos quadrados (LS) foram obtidas a partir de um modelo de Análise de Covariância (ANCOVA) com tratamento como efeito fixo e troponina padronizada na linha de base como covariável.
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Linha de base, antes da ICP (não superior a 48 horas após a randomização)
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Porcentagem de participantes com incidência de todos os enxertos de revascularização miocárdica (CABG) ou trombólise não CABG em sangramento grave de infarto do miocárdio (TIMI)
Prazo: Primeira dose de ataque (LD) até 7 dias após a primeira LD
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A porcentagem de participantes é o número total de participantes com CABG ou sangramento maior TIMI não CABG dividido pelo número de participantes no braço de tratamento multiplicado por 100.
Os eventos de endpoint foram julgados pelo Comitê de Endpoint Clínico.
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Primeira dose de ataque (LD) até 7 dias após a primeira LD
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Resumo da morte por qualquer causa
Prazo: Randomização por 30 dias
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Todas as mortes, independentemente da possível relação, foram julgadas pelo Clinical Endpoint Committee (CEC) e são relatadas nesta tabela.
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Randomização por 30 dias
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2009
Conclusão Primária (Real)
1 de janeiro de 2013
Conclusão do estudo (Real)
1 de fevereiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
17 de novembro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
17 de novembro de 2009
Primeira postagem (Estimativa)
18 de novembro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
28 de fevereiro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de janeiro de 2014
Última verificação
1 de janeiro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12918
- H7T-MC-TADF (Outro identificador: Eli Lilly and Company)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .