Population Pharmacokinetics of Apixaban in Asian Patients With Atrial Fibrillation

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Conditions studied: Non Valvular Atrial Fibrillation (nv AF)

In brief

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.

Key facts

Study ID

NCT07747948

Run by

Chulalongkorn University

People needed

200

Starts

2026-09-01

Expected to finish

2027-04-30

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Patients with gastrointestinal disorders that significantly affect drug absorption, such as short bowel syndrome

Where it is running

• Faculty of Medicine, Chulalongkorn University — Pathum Wan, Bangkok, Thailand

Full record on ClinicalTrials.gov

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