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- Ensaio Clínico NCT01248351
Reversibility of Dual Antiplatelet Therapy by Platelets
Reversibility of Dual Antiplatelet Therapy by Platelets.Phase II Study
Visão geral do estudo
Status
Condições
Descrição detalhada
Dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to prevent thrombotic complications in patients with high platelet reactivity following plaque rupture in acute coronary syndromes (ACS) or percutaneous coronary interventions. Current practice guidelines for antiplatelet therapy advocate a one to 12 months dual antiplatelet therapy after bare metal stent PCI and a 12 months dual antiplatelet therapy after PCI in patients with ACS and drug eluting stent PCI. Although oral antiplatelet therapy is associated with both, short- as well as long-term clinical efficacy, irreversible platelet inhibition carries a substantial risk of bleeding particularly in patients presenting for surgery. Empiric therapy of bleeding consists of platelet transfusion. However, there are currently no pharmacodynamic studies assessing the effect of stored platelets on in-vitro platelet function tests.
Healthy volunteers will donate platelets, take aspirin and clopidogrel for 3 days (loading dose aspirin 300 mg, clopidogrel 300 mg, maintenance dose aspirin 100 mg, clopidogrel 75 mg) and platelets will be retransfused on the 4th day. Pharmacodynamic measurements of platelet function will be performed at baseline, after drug intake before retransfusion, immediately after retransfusion and 24 hours thereafter.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Graz, Áustria, 8036
- Department of anesthesia and intensive care medicine, Medical Univerity of Graz
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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:
- Informed consent
- Healthy volunteers, male or female (after exclusion of pregnancy if they are on birth control pill or have a contraceptive coil implanted)
- Age of consent
- Weight: 70 kg - 100 kg
- Platelet count 240 000 to 440 000/µL
- Hematocrit > 40%
- readiness to refrain from any activities prone to injury during the study period.
Exclusion criteria:
- Allergy against aspirin or clopidogrel
- History of bleeding
- History of peptic ulcer
- Intake of aspirin or NSAR during the last ten days before screening
- Gastrointestinal disease precluding resorption of aspirin and clopidogrel
- Scheduled surgery
- Any current medication
- History of hepatic disease
- 20µm ADP induced aggregation < 60% at screening
- CYP2C19 polymorphisms
- Donation of blood within the preceding 4 weeks
- Neurotic disease
- Current smoking
- Drug addiction
- Intake of grapefruits during the last 10 days before
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: autologous stored platelets
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Administration of autologous stored platelets
administration of autologous stored platelets
transfusion of autologous stored platelets
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pharmacodynamic assessment of platelet function as assessed by 5 and 20 micromolar ADP
Prazo: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pharmacodynamic assessment of platelet function as assessed by 20 mM arachidonic acid
Prazo: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
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Pharmacodynamic assessment of platelet function as assessed by Vasodilator stimulated phosphoprotein (VASP) phosphorylation (platelet reactivity index; PRI)
Prazo: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
|
Pharmacodynamic assessment of platelet function as assessed by expression of GP IIb/IIIa receptors and P-selectin (Mean fluorescence intensity %)
Prazo: 7 days
|
pharmacodynamic measurements of platelet function will be assessed at baseline, after 3 days administration of aspirin and clopidogrel (300 mg loading with aspirin and clopidogrel, maintenance with 100 mg aspirin and 75 mg clopidogrel, respectively) after retransfusion of stored platelets and 24 hours thereafter
|
7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mahla Elisabeth, MD, Dept. of Anesthesia and Intensive Care Medicine, Medical University of Graz
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- PAC_2009
- 2009-018108-17 (Número EudraCT)
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