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
Qualifiers
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 design
Treatments tested in this trial
- Apixaban
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Chulalongkorn University
Lead sponsor
Thammasat University
Sponsor institution
Thammasat University
Collaborator
King Chulalongkorn Memorial Hospital
Collaborator
Source ClinicalTrials.gov