Can we predict apixaban levels in asian hearts?
NCT ID NCT07747948
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This observational study looks at how the blood thinner apixaban is processed in the bodies of Asian patients with atrial fibrillation. Researchers will analyze existing medical records and blood concentration data from about 200 patients to understand how factors like kidney function and body weight affect drug levels. The goal is to identify what influences apixaban clearance and distribution, which could help personalize dosing in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apixaban (oral tablet, 2.5 mg or 5 mg twice daily)
- What this could lead to
- If successful, this could help doctors tailor apixaban dosing for Asian patients with atrial fibrillation, potentially improving safety and effectiveness.
- What could go wrong
- This is an observational study using existing data, so it cannot prove cause and effect. Results may not apply to all patients, and the analysis depends on the quality of the collected records.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Faculty of Medicine, Chulalongkorn University
Pathum Wan, Bangkok, 10330, Thailand