Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2021-07-31

Brief Summary

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The purpose of this study is to assess pharmacokinetics and pharmacodynamics of Apixaban and clinical outcome of Apixaban in Thai patients with nonvalvular atrial fibrillation with varying degree of creatinine clearance

Detailed Description

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This study is divided into two parts.

The first part is a multiple dose pharmacokinetic and pharmacodynamics study of Apixaban in patient with stable renal function. The primary purpose of this study is to provide a clear understanding of the effect of creatinine clearance on pharmacokinetics and pharmacodynamics of Apixaban among Thai patients with nonvalvular atrial fibrillation. To assess the pharmacokinetics and pharmacodynamics of Apixaban, This study will enroll 30 subjects who meet the inclusion criteria.

The second part of this study will retrospectively determine the occurrent of clinical outcome between patients who were prescribed apixaban dose concordant and discordant to the drug leaflet. A total of 241 subjects will be recruited. The follow up period will begin from the time of initiation of apixaban until occurrent of stoke, transient ischemic attack, systemic embolism, bleeding, or death.

Conditions

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Atrial Fibrillation

Keywords

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Apixaban Pharmacokinetic Pharmacodynamic Cardioembolic stroke Ischemic stroke

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Apixaban dose concordant to leaflet

Patients who were prescribed apixaban dose concordant to apixaban leaflet approved by Thai FDA

No interventions assigned to this group

Apixaban dose discordant to leaflet

Patients who were prescribed apixaban dose discordant to apixaban leaflet approved by Thai FDA

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with nonvalvular atrial fibrillation
* Patients who is receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.

* Patients with nonvalvular atrial fibrillation
* Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.

Exclusion Criteria

* Pregnant or lactating
* End stage renal disease patients who required chronic renal replacement therapy to sustained life
* History of acute kidney injury within the previous 3 months
* Severe hepatic impairment (Child-Pugh class C)
* Any gastrointestinal disorder that could impact the absorption of study drug
* CYP3A4 Moderate/Strong Inhibitors: ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, diltiazem, and St.John's Wort

Part II

* Pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pheeraphat Sarppreuttikun

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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632/63

Identifier Type: -

Identifier Source: org_study_id