- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03658005
Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI (PLATIME)
Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients
The purpose of this study is to assess:
- the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
- ticagrelor and its metabolite levels by LC-MS/MS
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. It is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. Contrary to other P2Y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. It had been previously showed that stimulation of platelets by ADP or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and P2Y12 receptors towards the lipid rafts. This suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor.
In this context, the aim of the study is to assess:
- the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
- ticagrelor and its metabolite levels by LC-MS/MS.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jennifer Lagoutte-Renosi, MPharm
- Número de teléfono: +33370632379
- Correo electrónico: jlagoutte@chu-besancon.fr
Ubicaciones de estudio
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Besançon, Francia, 25000
- Reclutamiento
- Chu Besancon
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients aged over 18 years and less than 90 years,
- Patients admitted for myocardial infarction treated with ticagrelor in association with aspirin.
- Patients affiliated to a social security system (or be a beneficiary thereof);
- Sign written informed consent indicating that they have understood the study procedures and objectives, and that they accept to participate and adhere to the study requirements.
Exclusion Criteria:
- Patients with limited legal capacity or patients under legal guardianship
- Patients under judicial protection
- Patients not affiliated to any social security system
- Patients taking any antiplatelet agent other than ticagrelor Patients taking ticagrelor for <48 hours (treatment not stabilised) Patients with hemoglobin concentration <10 g/dL on the most recent blood test
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Study cohort
Adult (>18 years, <90 years) patients admitted and treated for acute myocardial infarction, and whose treatment includes ticagrelor in association with aspirin. Blood samples will be taken at 3 timepoints between two doses of ticagrelor (taken at 12 hours interval). |
3 blood samples, for a maximum of 60mL, will be taken at 0-3h, 3-6h and >6h, between two doses of ticagrelor (taken at 0 and 12 hours).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
concentration of unbound ticagrelor and its metabolite
Periodo de tiempo: at 3 hours after administration of the first dose of ticagrelor
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Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
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at 3 hours after administration of the first dose of ticagrelor
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concentration of unbound ticagrelor and its metabolite
Periodo de tiempo: at 6 hours after administration of the first dose of ticagrelor
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Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
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at 6 hours after administration of the first dose of ticagrelor
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concentration of unbound ticagrelor and its metabolite
Periodo de tiempo: at 12 hours after administration of the first dose of ticagrelor
|
Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
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at 12 hours after administration of the first dose of ticagrelor
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Assess the method of determination of ticagrelor concentration
Periodo de tiempo: at 3 hours after administration of the first dose of ticagrelor
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Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
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at 3 hours after administration of the first dose of ticagrelor
|
Assess the method of determination of ticagrelor concentration
Periodo de tiempo: at 6 hours after administration of the first dose of ticagrelor
|
Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
|
at 6 hours after administration of the first dose of ticagrelor
|
Assess the method of determination of ticagrelor concentration
Periodo de tiempo: at 12 hours after administration of the first dose of ticagrelor
|
Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
|
at 12 hours after administration of the first dose of ticagrelor
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicolas Meneveau, MD, PhD, Dept of Cardiology, CHU Besancon
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P/2018/371
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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