Population Pharmacokinetics of Apixaban in Asian Patients With Atrial Fibrillation | NCT07747948

NCT07747948

Overview

NCT ID: NCT07747948
Lead Sponsor: Chulalongkorn UniversityOTHER
Official Title: Population Pharmacokinetics of Apixaban in Asian Patients With Atrial Fibrillation
Brief Summary: 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:

What are the specific pharmacokinetic parameters and their variabilities for apixaban in this patient population?

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.
Conditions: Non Valvular Atrial Fibrillation (nv AF)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Apr 30, 2027Estimated

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 200Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Faculty of Medicine, Chulalongkorn University

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Asian Atrial Fibrillation Apixaban Cohort

The study group comprises Asian patients diagnosed with non-valvular atrial fibrillation who are receiving apixaban as part of their standard clinical care. To ensure valid pharmacokinetic analysis, all participants must have reached a steady-state drug concentration, defined as receiving a fixed dose of 2.5 mg or 5 mg twice daily for at least three consecutive days. The group includes patients from two major tertiary centers: King Chulalongkorn Memorial Hospital in Thailand and National Taiwan University Hospital in Taiwan. This cohort is characterized by two levels of data density: an intensive sampling subgroup (n=24) and a sparse sampling subgroup (n=180). As this is a retrospective observational study, no experimental intervention is administered; the "intervention" of interest is the standard therapeutic exposure to apixaban, which is analyzed to identify the impact of clinical covariates such as renal function, body weight, and drug-drug interactions.

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