Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
研究概览
简要总结
The purpose of this study is to assess pharmacokinetics and pharmacodynamics of Apixaban and clinical outcome of Apixaban in Thai patients with nonvalvular atrial fibrillation with varying degree of creatinine clearance
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
结局指标
主要结局
Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
时间窗: pre-dose to 12 hours post-dose
AUC(0-12) is measured by plasma concentration of apixaban over time. The mean are reported in nanogram hours per milliliter (ng\*h/mL).
次要结局
- Number of patients with event of major or nonmajor (International Society on Thrombosis and Hemostasis [ISTH]) bleeding during the follow up period(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)
- Number of participants with first event of stroke, transient ischemic attack, systemic embolism (SE), or all-cause death during the follow up period(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)
研究者
Pheeraphat Sarppreuttikun
Principle Investigator
Chulalongkorn University