Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Bangkok
-
Pathum Wan、Bangkok、泰国、10330
- King Chulalongkorn Memorial Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Apixaban dose concordant to leaflet
Patients who were prescribed apixaban dose concordant to apixaban leaflet approved by Thai FDA
|
|
Apixaban dose discordant to leaflet
Patients who were prescribed apixaban dose discordant to apixaban leaflet approved by Thai FDA
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
大体时间：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).
|
pre-dose to 12 hours post-dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with first event of stroke, transient ischemic attack, systemic embolism (SE), or all-cause death during the follow up period
大体时间：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
|
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.
|
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 patients with event of major or nonmajor (International Society on Thrombosis and Hemostasis [ISTH]) bleeding during the follow up period
大体时间：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
|
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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Steady-state maximum observed plasma concentration of Apixaban
大体时间：pre-dose to 12 hours post-dose
|
Maximum observed drug concentration in plasma after administration (Cmax) of apixaban at steady-state
|
pre-dose to 12 hours post-dose
|
|
Steady-state minimum observed plasma concentration of Apixaban
大体时间：pre-dose to 12 hours post-dose
|
Minimum observed drug concentration in plasma after administration (Cmin) of apixaban at steady-state
|
pre-dose to 12 hours post-dose
|
|
Steady state elimination of half-life of Apixaban
大体时间：pre-dose to 12 hours post-dose
|
Mean terminal phase plasma t½ of apixaban at steady-state
|
pre-dose to 12 hours post-dose
|
|
Steady state Anti-Xa activity
大体时间：pre-dose to 12 hours post-dose
|
Anti-Xa activity will be measured by chromogenic anti-Xa activity assay
|
pre-dose to 12 hours post-dose
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.