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- Ensaio Clínico NCT00229515
Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Administered With the Single High-Dose Bolus Versus Abciximab and Sirolimus Eluting Stent Versus Bare Metal Stent in Acute Myocardial Infarction - MULTI-STRATEGY Trial
Visão geral do estudo
Status
Condições
Descrição detalhada
The combination abciximab plus bare metal stent (BMS) is currently considered the standard therapy for AMI. The use of sirolimus eluting stent (SES) is related to a reduction of the need for urgent target vessel revascularization (TVR). With current acquisition prices for abciximab and SES, replacing abciximab with tirofiban, administered as a single high-dose bolus (SHDB) regimen, is a promising strategy that would preserve financial resources. In a recent study the combination tirofiban and SES resulted to be associated to an overall lower major adverse cardiovascular events (MACE) rate with respect to the abciximab plus BMS. However, since no conclusion can be drawn yet regarding the relative contribution of a specific GP IIb/IIIa inhibitor or a stent type with respect to the other, the combination of abciximab and SES may be associated to an even lower event rate with respect to SHDB tirofiban and SES, thus offsetting the higher initial cost.
Comparison(s): four strategies (SHDB tirofiban + BMS, SHDB tirofiban + SES, abciximab + BMS, abciximab + SES) are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Ferrara, Itália, 44100
- Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- ST segment elevation myocardial infarction
- Schedule for primary percutaneous coronary intervention
- Informed consent
Exclusion Criteria:
- Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
- History of bleeding diathesis or allergy to the studies drug
- Major surgery within 30 days
- Limited life expectancy, e.g. neoplasms, others
- Pregnancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 1
Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
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Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
Outros nomes:
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Experimental: 2
Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
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Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
Outros nomes:
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Experimental: 3
tirofiban infusion followed by bare metal stent implantation
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Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation
Outros nomes:
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Experimental: 4
tirofiban and sirolimus-eluting stent
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Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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The evaluation of the degree of ST-segment resolution after the mechanical intervention.
Prazo: 90 minutes after last balloon inflation
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90 minutes after last balloon inflation
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The cumulative rate of death for any cause, reinfarction and target vessel revascularisation
Prazo: 8 months
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8 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.
Prazo: at any time during follow-up
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at any time during follow-up
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The evaluation of the cost-effectiveness of the involved experimental treatments.
Prazo: 8 months, 1,3 and 5 years
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8 months, 1,3 and 5 years
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stent thrombosis according to the ARC classification
Prazo: any time during follow-up
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any time during follow-up
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the degree of cumulative or single lead ST segment resolution at time frames different from the primary endpoint. the degree of residual ST segment elevation.
Prazo: immediately after intervention, at 90 minutes and at discharge
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immediately after intervention, at 90 minutes and at discharge
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bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.
Prazo: at 30 days, 1 year, 3 and 5 years
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at 30 days, 1 year, 3 and 5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Roberto Ferrari, Professor, Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy
Publicações e links úteis
Publicações Gerais
- Valgimigli M, Percoco G, Malagutti P, Campo G, Ferrari F, Barbieri D, Cicchitelli G, McFadden EP, Merlini F, Ansani L, Guardigli G, Bettini A, Parrinello G, Boersma E, Ferrari R; STRATEGY Investigators. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA. 2005 May 4;293(17):2109-17. doi: 10.1001/jama.293.17.2109.
- Garg S, Sarno G, Serruys PW, Rodriguez AE, Bolognese L, Anselmi M, De Cesare N, Colangelo S, Moreno R, Gambetti S, Monti M, Bristot L, Bressers M, Garcia-Garcia HM, Parrinello G, Campo G, Valgimigli M; STRATEGY and MULTISTRATEGY Investigators. Prediction of 1-year clinical outcomes using the SYNTAX score in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a substudy of the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) trials. JACC Cardiovasc Interv. 2011 Jan;4(1):66-75. doi: 10.1016/j.jcin.2010.09.017.
- Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Colangelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R; Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY) Investigators. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial. JAMA. 2008 Apr 16;299(15):1788-99. doi: 10.1001/jama.299.15.joc80026. Epub 2008 Mar 30.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Isquemia
- Processos Patológicos
- Necrose
- Isquemia do miocárdio
- Doenças cardíacas
- Doenças cardiovasculares
- Doenças Vasculares
- Infarto do miocárdio
- Infarte
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Agentes Fibrinolíticos
- Agentes Moduladores de Fibrina
- Inibidores da agregação plaquetária
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes de proteção
- Agentes antibacterianos
- Adjuvantes Imunológicos
- Antibióticos, Antineoplásicos
- Antifúngicos
- Anticoagulantes
- Indutores de interferon
- Agentes de proteção contra radiação
- Tirofiban
- Sirolimo
- Abciximabe
- polissacarídeo-K
Outros números de identificação do estudo
- TSES-02-III
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