- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02514642
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease
28 de septiembre de 2015 actualizado por: First Affiliated Hospital of Harbin Medical University
Safety and Efficacy of Low-dose Ticagrelor in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Trial
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS).
Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation.
However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs.
In Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively.
But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients.
A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects.
This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients.
In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients.
Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS).
Guideline recommendations on the use of dual antiplatelet therapy (DAPT) have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for patients who have an ACS with or without ST-segment elevation.
However, few East Asian patients (or those of East Asian descent) have been included in these trials to assess the use of these drugs.
In addition, a growing body of data supported that East Asian might have different adverse event profiles (thrombophilia and bleeding) and "therapeutic window" compared with white subjects.
Furthermore, "East Asian paradox" phenomenon has been also described that East Asian patients have a higher prevalence of platelet reactivity during DAPT, but an ischaemic event rate following percutaneous coronary intervention (PCI) or ACS is similar or even lower than white patients.
In Korea and Japan, it has been reported that low doses of ticagrelor might have a more potent inhibition of platelet aggregation (IPA) than clopidogrel (75 mg once daily) in healthy subjects and patients with stable coronary artery disease, respectively.
But it is still not clear whether a low dose of ticagrelor is superior to clopidogrel in a large population of Chinese ACS patients.
A recent study on pharmacokinetics and tolerability of ticagrelor has found that maximum plasma concentration and area under the plasma concentration-time curve of ticagrelor (90 mg twice daily) and its active metabolite (AR-C124910XX) tended to be approximately 40% higher in healthy Chinese volunteers compared with Caucasian subjects.
This data also suggested that a low dose of ticagrelor might be more appropriate for Chinese ACS patients.
In view of a large diurnal variation with a single daily dose, a lower dose twice daily may be a better choice for Chinese patients.
Therefore, the investigators performed this randomized, single-blind, crossover clinical trial to observe the efficacy and safety of low-dose ticagrelor (22.5 mg twice daily) in comparison to clopidogrel (75mg once daily) in Chinese patients with stable coronary artery disease.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
30
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Meijiao He, MM
- Número de teléfono: 86-451 -85555673
- Correo electrónico: hemeijiao99@sina.com
Ubicaciones de estudio
-
-
California
-
San Diego, California, Estados Unidos, 92101-92117
- Reclutamiento
- VerifyNow
-
Contacto:
- Meijiao He, Master
- Número de teléfono: 518-393-2200
- Correo electrónico: customerservice@accriva.com
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Stable Coronary Artery Disease
- stable angina
- low-risk unstable angina
- variant angina
- patients with asymptomatic with appropriate therapy(including percutaneous coronary intervention).
Exclusion Criteria:
- ACS
- planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists, or anticoagulant therapy during the study period
- platelet count <100g/L
- creatinine clearance rate < 30ml/min
- diagnosed as respiratory or circulatory instability (cardiac shock, severe congestive heart failure NYHA II-IV or left ventricular ejection fraction < 40%)
- a history of bleeding tendency
- aspirin, ticagrelor or clopidogrel allergies
- diabetes.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: clopidogrel
Observar la diferente seguridad y eficacia entre ticagrelor a dosis bajas y clopidogrel a dosis convencional.
|
low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
Otros nombres:
clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
Otros nombres:
|
Experimental: low-dose ticagrelor
To observe the safety and efficacy of low-dose ticagrelor in Chinese patients withStable Coronary Artery Disease
|
low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
Otros nombres:
clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
P2Y12 reaction units (PRU)
Periodo de tiempo: up to 5 months
|
up to 5 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
inhibition of platelet aggregation (IPA)
Periodo de tiempo: up to 5 months
|
up to 5 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Yue Li, MD, Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2015
Finalización primaria (Anticipado)
1 de octubre de 2015
Finalización del estudio (Anticipado)
1 de noviembre de 2015
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
3 de agosto de 2015
Publicado por primera vez (Estimar)
4 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de septiembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
28 de septiembre de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Enfermedad coronaria
- 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
- Ticagrelor
- Clopidogrel
Otros números de identificación del estudio
- SCAD-201523
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. .
Ensayos clínicos sobre low-dose ticagrelor
-
University of South CarolinaMedical University of South Carolina; National Institute on Deafness and Other...Terminado
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical... y otros colaboradoresReclutamiento
-
University of MinnesotaReclutamientoTrasplante de órganos sólidosEstados Unidos
-
Dose Safety Inc.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Benaroya...SuspendidoGlucosa, sangre baja | Glucosa, sangre altaEstados Unidos
-
National Institute of Diabetes and Digestive and...TerminadoObesidad | Pérdida de peso | Aumento de peso | Terapia de dieta | Terapia NutricionalEstados Unidos
-
Anumana, Inc.Mayo ClinicAún no reclutandoFracción de eyección ventricularEstados Unidos
-
Memorial Sloan Kettering Cancer CenterActivo, no reclutandoTumores sólidos | Entrenamiento aeróbico preoperatorioEstados Unidos
-
DePuy InternationalTerminadoArtroplastia, Reemplazo, RodillaIrlanda
-
Fondazione Policlinico Universitario Agostino Gemelli...DesconocidoMortalidad perioperatoriaItalia
-
University of California, Los AngelesTerminadoEstado prediabéticoEstados Unidos