An observational study in Atrial Fibrillation, sponsored by Chulalongkorn University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by Chulalongkorn University · Observational
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
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 241 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Thai patients with nonvalvular atrial fibrillation receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, or systemic embolism.
Part I
Inclusion Criteria:
Exclusion Criteria:
Part II
Inclusion Criteria:
Exclusion Criteria:
Patients who were prescribed apixaban dose concordant to apixaban leaflet approved by Thai FDA
Patients who were prescribed apixaban dose discordant to apixaban leaflet approved by Thai FDA
Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
AUC(0-12) is measured by plasma concentration of apixaban over time. The mean are reported in nanogram hours per milliliter (ng\*h/mL).
Time frame: pre-dose to 12 hours post-dose
Number of participants with first event of stroke, transient ischemic attack, systemic embolism (SE), or all-cause death during the follow up period
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.
Time frame: 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
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.
Time frame: 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
Steady-state maximum observed plasma concentration of Apixaban
Maximum observed drug concentration in plasma after administration (Cmax) of apixaban at steady-state
Time frame: pre-dose to 12 hours post-dose
Steady-state minimum observed plasma concentration of Apixaban
Minimum observed drug concentration in plasma after administration (Cmin) of apixaban at steady-state
Time frame: pre-dose to 12 hours post-dose
Steady state elimination of half-life of Apixaban
Mean terminal phase plasma t½ of apixaban at steady-state
Time frame: pre-dose to 12 hours post-dose
Steady state Anti-Xa activity
Anti-Xa activity will be measured by chromogenic anti-Xa activity assay
Time frame: pre-dose to 12 hours post-dose
Plan to share: No
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This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Chulalongkorn University