Impact of Clopidogrel Dose Adjustment According to Platelet Reactivity Monitoring in Patients With High on Treatment Platelet Reactivity Undergoing Percutaneous Coronary Intervention
Acute coronary syndromes are related to the development of a platelet derived thrombus on a ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a significantly reduced the risk of major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). However despite these therapeutic innovations, the rate of MACE in patients treated using PCI and particularly in those suffering of an acute coronary syndrome is around 5% in randomized trials. Within the factors associated with MACE, high on treatment platelet reactivity following clopidogrel loading dose has been identified as a key factor. In fact it is widely recognized that there is a large inter individual variability in clopidogrel responsiveness. In addition several authors have demonstrated a strong link between high on treatment platelet reactivity following clopidogrel loading dose and the occurrence of post PCI MACE. Vasodilator Phosphoprotein index measurement (VASP index) enables a reproducible, standardized and specific assessment of clopidogrel responsiveness.
The investigators previous works have demonstrated that a VASP index ≥ 50% had a high negative predictive value for post PCI MACE in patients undergoing PCI and that tailored clopidogrel loading dose in order to obtain a VASP index < 50% before PCI resulted in a reduction in the rate of post PCI MACE.
Prasugrel is a new generation thienopyridine with a faster and more powerful anti platelet effect compared to clopidogrel. It was shown to be superior to clopidogrel to reduce post PCI MACE in acute coronary syndromes. However in this randomized trial prasugrel achieved an excessive blockade of platelet reactivity responsible for a significant increase in bleeding events in some patients and an insufficient blockade in up to 325% of the remaining patients.
Therefore the investigators hypothesized that a strategy of individually tailored loading and maintenance dose of clopidogrel may be superior to prasugrel standard therapy in achieving an optimal platelet reactivity inhibition in acute coronary syndrome patients undergoing PCI.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Marseille, Francia, 13354
- Assistance Publique Hôpitaux de Marseille
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subject in front of benefited from a coronary angioplasty with setting-up of an endoprothese for a SCA
- Subject agreeing to be followed over a period of 1 month
- Subject agreeing to participate in the research and having given its signed enlightened consent
Exclusion Criteria:
Subject minor or of more than 75 years old
- Subject presenting a rate of red blood cells < 4 G/l or a thrombocytopenia > 100 000 / mm3 plaques
- unaffiliated Subject in a benefit system
- pregnant or breast-feeding Woman: a pregnancy test will be realized in a systematic way, as well as a stake under contraception of the women old enough to procreate
- Intolerance or allergy in the aspirin or in the clopidogrel
- Pathology associated with a life expectancy 6-month-old subordinate according to the investigator
- haemorrhagic Syndrome threatening the vital forecast, the intra-cranial tumor
- Contraindication in one of the medicines of the study
- Severe hepatocellular incapacity
- Fibrinolyse meadow or hospital intra
- Ceaseless ventricular arrhythmias
- State of cardiogenic shock
- History of cerebral vascular accident
- Weight lower than 60 kg
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: CLOPIDOGREL GROUP
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600 mg clopidogrel will be administered during the first 6 to 12 hours then a measure of platelets reactivity will be done. An additional administration of clopidogrel (600 mg) could be done every 6 hours until to obtain a VASP <50%. No more than 3 * 600mg of clopidogrel will be authorized in this protocol. Then for patient which have received more than one dose of clopidogrel 600mg , 150 mg per day of clopidogrel will be administrated, for which who have received only one dose of 600mg of clopidogrel , 75 mg per day will be administrated during one month at least. |
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Comparador activo: PRASUGREL GROUP
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60 mg the first day then 10 mg per day during one month
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the biological efficacy of tailored clopidogrel therapy
Periodo de tiempo: 12 months
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To compare the biological efficacy of tailored clopidogrel therapy according to the VASP index and prasugrel standard therapy in acute coronary syndromes patients undergoing PCI.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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clinical efficacy
Periodo de tiempo: 12 MONTHS
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Baseline in Systolic Blood Pressure at 6 months
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12 MONTHS
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Tolerability
Periodo de tiempo: 12 MONTHS
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adverse event outcome at 6 months
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12 MONTHS
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- El síndrome coronario agudo
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la agregación plaquetaria
- Antagonistas del receptor P2Y purinérgico
- Antagonistas del receptor P2 purinérgico
- Antagonistas purinérgicos
- Agentes Purinérgicos
- Clopidogrel
- Clorhidrato de prasugrel
Otros números de identificación del estudio
- 2010-020095-32
- 2009-39 (Otro identificador: AP HM)
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