Not Yet RecruitingNot Applicable

Population Pharmacokinetics of Apixaban in Asian Patients With Atrial Fibrillation

Thailand200 participantsStarted 2026-09-01

Plain-language 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: 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is studying how apixaban moves through the body specifically in Asian patients with atrial fibrillation — does my ethnic background or body type affect how well apixaban is already working for me, and is that a reason to consider being part of this kind of study?
2Since this trial is focused on measuring drug clearance and distribution rather than testing a new treatment, what would actually happen to my care during the study — would I be taking apixaban anyway, and what additional tests or procedures would be involved?
3The trial isn't recruiting yet, so if my doctor thinks it could be relevant for me, how long might the wait be before it opens, and should I be starting standard anticoagulation treatment in the meantime?
4Because this is a pharmacokinetics study rather than a Phase 2 or 3 efficacy trial, what benefit would I personally get from participating, versus simply being treated with apixaban as standard care outside of a study?
5Are there specific things about my health history — like kidney function, other medications I take, or my weight — that could affect how my body processes apixaban, and would results from this study potentially help tailor dosing for patients like me in the future?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Apparent Oral Clearance of Apixaban

Timeframe: At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).

Apparent Volume of Distribution

Timeframe: At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).

Trial details

NCT IDNCT07747948

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Non Valvular Atrial Fibrillation (nv AF) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Apparent Oral Clearance of Apixaban

Timeframe: At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).

Apparent Volume of Distribution

Timeframe: At steady state (following at least 3 days of consistent dosing), through completion of plasma sampling (up to 12 hours post-dose).