Population Pharmacokinetics of Apixaban in Asian Patients With Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChulalongkorn University
About this trial
The goal of this observational study is to learn about the variability of apixaban blood levels and identify the clinical factors that influence them in Asian patients with atrial fibrillation. The main questions it aims to answer are:
1. What are the specific pharmacokinetic parameters and their variabilities for apixaban in this patient population? 2. Which clinical factors, such as kidney function or body weight, are the primary predictors of how apixaban is cleared and distributed in the body?
Participants will be asked to give consent to allow researchers to use their existing electronic outpatient medical records and previously collected blood concentration data for analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and older
Patients diagnosed with atrial fibrillation
Receiving apixaban at a fixed dose of 2.5 mg or 5 mg twice daily for at least 3 consecutive days
Disqualifiers
Patients with end-stage renal disease (ESRD) receiving renal replacement therapy
Patients with a history of acute kidney injury (AKI) within 3 months prior to study enrollment
Patients with cirrhosis of Child-Pugh class C severity
Patients receiving moderate to strong inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp), such as ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort (Patients receiving amiodarone, verapamil, or diltiazem are not excluded and will be included for covariate analysis)
Trial population
The study population is drawn from outpatients receiving clinical care at two major tertiary academic medical centers in Asia: King Chulalongkorn Memorial Hospital (KCMH) in Bangkok, Thailand, and National Taiwan University Hospital (NTUH) in Taipei, Taiwan. At KCMH, participants are primarily sourced from the Outpatient Department (OPD), specifically within the Division of Cardiology and the Division of Neurology. At NTUH, participants are identified through clinical pharmacy records and the hospital's medical databases. This population represents a real-world cohort of Asian patients managed for atrial fibrillation in diverse clinical settings. Potential participants are initially identified by researchers through a systematic screening of Electronic Medical Records (EMR) using specific diagnostic codes (ICD-10) and medication history, followed by direct contact for informed consent.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Apixaban
DrugApixaban is administered as an oral tablet in fixed doses of 2.5 mg or 5 mg twice daily. The intervention is provided as part of standard clinical care for patients diagnosed with non-valvular atrial fibrillation. For the purposes of this pharmacokinetic analysis, the intervention requires a minimum duration of 3 consecutive days of consistent dosing to ensure that the drug has reached steady-state plasma concentrations prior to data collection.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Asian Atrial Fibrillation Apixaban Cohort1 intervention
Trial outcomes
Primary outcomes
1
Apparent Oral Clearance of Apixaban
Apparent oral clearance of apixaban estimated using Non-linear Mixed Effects Modeling (NONMEM, version 7.5).
Time frame
At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).2
Apparent Volume of Distribution
Apparent volume of distribution of apixaban estimated using Non-linear Mixed Effects Modeling (NONMEM, version 7.5).
Time frame
At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).Secondary outcomes
1
Apparent Intercompartmental Clearance of Apixaban
Apparent intercompartmental clearance estimated using Non-linear Mixed Effects Modeling (NONMEM, version 7.5) if a 2-compartment structural model is selected.
Time frame
At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).2
Apparent Peripheral Volume of Distribution of Apixaban
Apparent peripheral volume of distribution estimated using Non-linear Mixed Effects Modeling (NONMEM, version 7.5) if a 2-compartment structural model is selected.
Time frame
At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).Sponsors and contacts
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Chulalongkorn University
Lead sponsor
Thammasat University
Sponsor institution
Thammasat University
Collaborator
King Chulalongkorn Memorial Hospital
Collaborator
Source ClinicalTrials.gov
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