- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01534221
The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting (COPERNICOS)
Randomized Comparison of Outcome of Stenting in Unselected Patients in Everyday Clinical Practice
The superiority of a percutaneous coronary intervention (PCI) by one stent over another in terms of clinical outcome is usually documented in large randomized controlled trials (RCT). Although generated from selected study populations these data form the basis for evidence based practice (EBP) in the entire population of patients considered for coronary intervention. An inherent limitation of this approach is that study populations differ significantly from all comers in terms of patient characteristics and prognosis undermining the foundation for extrapolation of trial results to all comers. Furthermore, other trials are based on a "one-fits-all" concept, while the benefits of an "individual-tailored" approach that might be superior, is not investigated.
The Purpose of the current study is to
- Compare clinical outcome between several CE marked drug eluting stents
- Compare clinical outcome between several CE marked bare metal stents
- Compare clinical outcome in all comers with that of the selected study population of RCT's
- Evolve methods to compare clinical outcomes between the generalized "one-fits-all" versus the individualized or "individual-tailored" stent selection approaches
The Method employed is
- All comer PCI registry - single centre
- Randomisation of all eligible patients within the registry to one of several study stent
- Quality assurance in non-randomized population within the registry by periodical alternating the institutional standard stent
- Continuous follow up of all patients included the registry by means of systematic event detection and classification by an independent safety and end point committee
- Assessment of effects on quality of life by heart and health questionnaires
Outcome Measures
Primary endpoints:
- Composite of cardiac death, acute myocardial infraction and target vessel revascularisation
- Stent thrombosis
- A specifically developed Treatment Failure Rate classification
Secondary outcome measures include each of the above, target lesion revascularisation and total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.
Tertiary outcome measure is self reported quality of life based on health questionnaires on general health and cardiac symptoms.
Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment arms.
Prespecified Analysis include
- The MACE rates between stent types
- The Stent thrombosis rates between stent types
- The Treatment failure rates between stent types
- The randomized population versus non-randomized population
- The individualized versus the generalized Population
- QOL between stent types
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
All MACE and stent thromboses are adjudicated by an independent end point and safety committee chaired by Jørgen Jeppesen known from the very same task he executed in the SORT OUT II.
Further question may be answered by the four key investigators:
Steen Carstensen, Anders Galløe, Ole Havndrup, Lars Kjøller-Hansen
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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-
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Roskilde, Dinamarca, 4000
- Roskilde County Hospital
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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:
- to enter COPERNICOS registry for quality assessment: Each and every patient assigned to percutaneous coronary intervention will be included.
- to enter COPERNICOS randomization: If the patient fulfil the Helsinki declaration and have a Danish personal security identification number they are asked to give written informed consent to participate in the randomized study arms.
Exclusion Criteria to randomization:
- unconscious patients
- residents in other countries thereby escaping event detection
- patients unable to understand the rationale of the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Study group two
Endeavor resolute drug eluting stent
|
Biomatrix drug eluting stent
Outros nomes:
|
Comparador Ativo: Study group three
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
Outros nomes:
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Comparador Ativo: Study group four
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
Outros nomes:
|
Comparador Ativo: Study group five
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
Outros nomes:
|
Comparador Ativo: Study group one
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
MACE
Prazo: Five year
|
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
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Five year
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Stent thromboses
Prazo: Five year
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Definite, propable and possible
|
Five year
|
Treatment failure
Prazo: Five Years
|
A specifically developed Treatment Failure Classification
|
Five Years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Death of any cause
Prazo: One and five years
|
Ongoing quality assurance
|
One and five years
|
Self reported health questionnaires on general health and cardiac specific symptoms.
Prazo: One and five years
|
One and five years
|
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Cardiac death
Prazo: One and five years
|
One and five years
|
|
Myocardial infarction
Prazo: One and five years
|
One and five years
|
|
Target lesion revascularisation
Prazo: One and five years
|
One and five years
|
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Target vessel revascularisation
Prazo: One and five years
|
One and five years
|
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Stent thrombosis
Prazo: One and five years
|
One and five years
|
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Treatment Failure
Prazo: One and five years
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One and five years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anders M Galløe, Md.Ph.D., Zealand University Hospital
- Cadeira de estudo: Steen Carstensen, MD, Zealand University Hospital
- Cadeira de estudo: Ole Havndrup, MD, Zealand University Hospital
- Cadeira de estudo: Lars Kjøller-Hansen, MD, Zealand University Hospital
- Diretor de estudo: Gunnar VH Jensen, MD, Zealand University Hospital
- Diretor de estudo: Jørgen Jeppesen, MD, Glostrup University Hospital, Copenhagen
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
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
Outros números de identificação do estudo
- COPERNICOS
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 .
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