Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study is divided into two parts.
The first part is a multiple dose pharmacokinetic and pharmacodynamics study of Apixaban in patient with stable renal function. The primary purpose of this study is to provide a clear understanding of the effect of creatinine clearance on pharmacokinetics and pharmacodynamics of Apixaban among Thai patients with nonvalvular atrial fibrillation. To assess the pharmacokinetics and pharmacodynamics of Apixaban, This study will enroll 30 subjects who meet the inclusion criteria.
The second part of this study will retrospectively determine the occurrent of clinical outcome between patients who were prescribed apixaban dose concordant and discordant to the drug leaflet. A total of 241 subjects will be recruited. The follow up period will begin from the time of initiation of apixaban until occurrent of stoke, transient ischemic attack, systemic embolism, bleeding, or death.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Bangkok
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Pathum Wan, Bangkok, Tailandia, 10330
- King Chulalongkorn Memorial Hospital
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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
Part I
Inclusion Criteria:
- Patients with nonvalvular atrial fibrillation
- Patients who is receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Exclusion Criteria:
- Pregnant or lactating
- End stage renal disease patients who required chronic renal replacement therapy to sustained life
- History of acute kidney injury within the previous 3 months
- Severe hepatic impairment (Child-Pugh class C)
- Any gastrointestinal disorder that could impact the absorption of study drug
- CYP3A4 Moderate/Strong Inhibitors: ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, diltiazem, and St.John's Wort
Part II
Inclusion Criteria:
- Patients with nonvalvular atrial fibrillation
- Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Exclusion Criteria:
- Pregnant or lactating
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Apixaban dose concordant to leaflet
Patients who were prescribed apixaban dose concordant to apixaban leaflet approved by Thai FDA
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Apixaban dose discordant to leaflet
Patients who were prescribed apixaban dose discordant to apixaban leaflet approved by Thai FDA
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
Periodo de tiempo: pre-dose to 12 hours post-dose
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AUC(0-12) is measured by plasma concentration of apixaban over time.
The mean are reported in nanogram hours per milliliter (ng*h/mL).
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pre-dose to 12 hours post-dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with first event of stroke, transient ischemic attack, systemic embolism (SE), or all-cause death during the follow up period
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
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Diagnosis of stroke is defined as the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction).
Diagnosis of SE is defined as a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
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Number of patients with event of major or nonmajor (International Society on Thrombosis and Hemostasis [ISTH]) bleeding during the follow up period
Periodo de tiempo: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
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ISTH major bleeding criteria is defined as a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal. ISTH nonmajor bleeding is defined as clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. |
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Steady-state maximum observed plasma concentration of Apixaban
Periodo de tiempo: pre-dose to 12 hours post-dose
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Maximum observed drug concentration in plasma after administration (Cmax) of apixaban at steady-state
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pre-dose to 12 hours post-dose
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Steady-state minimum observed plasma concentration of Apixaban
Periodo de tiempo: pre-dose to 12 hours post-dose
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Minimum observed drug concentration in plasma after administration (Cmin) of apixaban at steady-state
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pre-dose to 12 hours post-dose
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Steady state elimination of half-life of Apixaban
Periodo de tiempo: pre-dose to 12 hours post-dose
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Mean terminal phase plasma t½ of apixaban at steady-state
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pre-dose to 12 hours post-dose
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Steady state Anti-Xa activity
Periodo de tiempo: pre-dose to 12 hours post-dose
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Anti-Xa activity will be measured by chromogenic anti-Xa activity assay
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pre-dose to 12 hours post-dose
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
- 632/63
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.
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