- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00357968
Trial in Subjects Undergoing Cardiac Catheterization With Planned Percutaneous Coronary Intervention With Stenting (PRINCIPLE)
Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Bad Krozingen, Alemanha, D-79189
- 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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Berlin, Alemanha, D-12203
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Giessen, Alemanha, 35392
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München, Alemanha, D-80636
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Tubingen, Alemanha, 72076
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Florida
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Jacksonville, Florida, Estados Unidos, 32209
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- 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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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
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Lille, França, 59037
- 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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Marseille, França, 13385
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Paris, França, 75013
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Tours, França, 37044
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Haifa, Israel, 31096
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Jerusalem, Israel, 91120
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Tel Hashomer, Israel, 52621
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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:
- Subjects greater than or equal to 18 years of age undergoing cardiac catheterization with planned percutaneous coronary intervention (if coronary anatomy is suitable) for an indication of chest pain +/or anginal equivalent felt by the treating physician to be related to coronary ischemia.
At least one of the following (a through c):
Functional study (exercise, or pharmacologic) within the past 8 weeks consistent with ischemia as manifested by at least one of the following:
- A reversible defect on nuclear imaging.
- A reversible wall-motion abnormality by echocardiography.
- Horizontal or down-sloping ST-depressions greater than 1 mm on electrocardiogram (ECG) (if no imaging performed).
- Prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
- A cardiac catheterization with at least one coronary artery lesion amenable to PCI (not yet performed) within 14 days prior to enrollment.
Exclusion Criteria:
- Known creatine kinase-myocardial bands (CK-MB)or cardiac troponin greater than the upper limit of normal at time of screening
- Planned PCI for acute myocardial infarction (MI) or planned PCI within 48 hours of fibrinolytic therapy for ST segment elevation myocardial infarction (STEMI)
- Have cardiogenic shock at the time of screening (systolic blood pressure 90 mm Hg associated with clinical evidence of end-organ hypoperfusion, or subjects requiring vasopressors to maintain systolic blood pressure over 90 mm Hg and associated with clinical evidence of end-organ hypoperfusion).
- Refractory ventricular arrhythmias
- Have New York Heart Association Class IV congestive heart failure
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Prasugrel to Clopidogrel
One time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days.
Patients cross-over to 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for the next 14 days.
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Administrado por via oral
Outros nomes:
Administered orally
Administered orally
Administered orally
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Comparador Ativo: Clopidogrel to Prasugrel
One time oral LD of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel taken orally once a day for 14 days.
Patients cross-over to 10 mg prasugrel and placebo tablets matched to clopidogrel taken orally once a day for the next 14 days.
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Administrado por via oral
Outros nomes:
Administered orally
Administered orally
Administered orally
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (μM) Adenosine Diphosphate (ADP) at 6 Hours After the Loading Dose
Prazo: 6 hours after loading dose
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IPA was defined as (1 - [maximal platelet aggregation(MPA) at 6 hours after study drug treatment]/[MPA before drug treatment]) x 100.
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6 hours after loading dose
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Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate After 14 Days of Maintenance Dose Treatment
Prazo: after 14 days of maintenance dosing
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Measures IPA during maintenance dosing before and after cross-over for each therapy. IPA was defined as (1 - [maximal platelet aggregation(MPA) at 14 days after study drug treatment]/[MPA before drug treatment]) x 100. |
after 14 days of maintenance dosing
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Inhibition of Platelet Aggregation to 20 μM Adenosine Diphosphate at 2 Hours After the Loading Dose
Prazo: 2 hours after loading dose
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IPA was defined as (1 - [maximal platelet aggregation (MPA) at 2 hours after study drug treatment]/[MPA before drug treatment]) x 100.
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2 hours after loading dose
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Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the First Maintenance Dose Phase
Prazo: after 14 days of treatment (before cross-over)
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Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL. |
after 14 days of treatment (before cross-over)
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Number of Participants With Non-Coronary Artery Bypass Graft (CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding During the Crossover Maintenance Dose Phase
Prazo: 14 days after cross-over
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Non-CABG-related TIMI major bleeding was any intracranial hemorrhage OR any clinically overt bleeding associated with a fall in hemoglobin >=5 gm/dL. Non-CABG-related TIMI minor bleeding was any clinically overt bleeding associated with a fall in hemoglobin >=3 gm/dL but <5 gm/dL. |
14 days after cross-over
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Number of Participants With Major Adverse Cardiac Events (MACE) During the First Maintenance Dose Phase
Prazo: after 14 days of treatment (before cross-over)
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Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
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after 14 days of treatment (before cross-over)
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Number of Participants With Major Adverse Cardiac Events During the Crossover Maintenance Dose Phase
Prazo: 14 days after cross-over
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Number of patients who met any of the following endpoints: cardiovascular death, myocardial infarction, stroke, subacute stent thrombosis, or urgent target vessel revascularization
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14 days after cross-over
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Number of Hyporesponsive Participants at 6 Hours After the Loading Dose
Prazo: 6 hours after loading dose
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Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
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6 hours after loading dose
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Number of Hyporesponsive Participants at the End of the First Maintenance Dose Phase
Prazo: From loading dose to day 15
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Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
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From loading dose to day 15
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Number of Hyporesponsive Participants at the End of the Crossover Maintenance Dose Phase
Prazo: 14 days after cross-over
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Number of patients with inhibition of platelet aggregation (IPA) with 20 uM adenosine diphosphate (ADP) <20%
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14 days after cross-over
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 2 Hours After the Loading Dose
Prazo: 2 hours after loading dose
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index.
A lower PRI indicates greater antiplatelet effect.
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2 hours after loading dose
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) at 6 Hours After the Loading Dose
Prazo: 6 hours after loading dose
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index.
A lower PRI indicates greater antiplatelet effect.
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6 hours after loading dose
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) 18 to 24 Hours After the Loading Dose
Prazo: 18 to 24 hours after loading dose
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean flourescence index.
A lower PRI indicates greater antiplatelet effect.
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18 to 24 hours after loading dose
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Platelet Reactivity Index Percent (PRI%) Measured by Vasodilator-stimulated Phosphoprotein (VASP) After 14 Days of Maintenance Dose Treatment
Prazo: after 14 days of maintenance dosing
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VASP phosphorylation in response to prostaglandin E1 (PGE1) with and without ADP was determined by whole-blood flow cytometry and was expressed as a platelet reactivity index (PRI).
PRI was defined as [(MFI(with PGE1) - MFI (with PGE1 and ADP))/MFI(with PGE1) x 100] where MFI is mean fluorescence index.
A lower PRI indicates greater antiplatelet effect.
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after 14 days of maintenance dosing
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Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) at 6 Hours After the Loading Dose
Prazo: 6 hours after loading dose
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Mean CK-MB at 6 hours after loading dose.
CK-MB is a biomarker for myonecrosis
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6 hours after loading dose
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Myonecrosis Measure: Creatine Kinase-Myocardial Bands (CK-MB) 18 to 24 Hours After the Loading Dose
Prazo: 18 to 24 hours after loading dose
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Mean CK-MB at 18-24 hours after loading dose.
CK-MB is a biomarker for myonecrosis.
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18 to 24 hours after loading dose
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Myonecrosis Measure: Cardiac Troponin at 6 Hours After the Loading Dose
Prazo: 6 hours after loading dose
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Mean troponin level at 6 hours after the loading dose.
Troponin is a biomarker for myonecrosis.
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6 hours after loading dose
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Myonecrosis Measure: Cardiac Troponin 18 to 24 Hours After the Loading Dose
Prazo: 18 to 24 hours after loading dose
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Mean troponin level at 18 to 24 hours after the loading dose.
Troponin is a biomarker for myonecrosis.
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18 to 24 hours after loading dose
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Colaboradores e Investigadores
Patrocinador
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
Termos MeSH relevantes adicionais
- Isquemia do miocárdio
- Doenças cardíacas
- Doenças cardiovasculares
- Doenças Vasculares
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doença cardíaca
- Doença arterial coronária
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores da agregação plaquetária
- Antagonistas Purinérgicos dos Receptores P2Y
- Antagonistas dos Receptores P2 Purinérgicos
- Antagonistas purinérgicos
- Agentes Purinérgicos
- Clopidogrel
- Cloridrato de Prasugrel
Outros números de identificação do estudo
- 10635
- H7T-MC-TABL (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 .
Ensaios clínicos em Prasugrel
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Eli Lilly and CompanyDaiichi Sankyo, Inc.Concluído
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University of PatrasConcluído
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Gyeongsang National University HospitalConcluídoSangramento | Síndrome Coronariana Aguda | Trombo de PlaquetasRepublica da Coréia
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University of FloridaConcluído
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University of MilanConcluído
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Medstar Health Research InstituteConcluídoSíndrome Coronariana AgudaEstados Unidos
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University of FloridaConcluídoDoença arterial coronáriaEstados Unidos
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VA Office of Research and DevelopmentConcluídoBypass da Artéria CoronáriaEstados Unidos
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Eli Lilly and CompanyConcluídoVoluntários SaudáveisRepublica da Coréia
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Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo CompanyConcluídoSíndrome Coronariana Aguda (SCA)Taiwan