Status:
UNKNOWN
Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Thammasat University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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 c...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Part I
- 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.
Exclusion
- 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
- Inclusion Criteria:
- Patients with nonvalvular atrial fibrillation
- Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Key Trial Info
Start Date :
December 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT04684732
Start Date
December 14 2020
End Date
July 1 2021
Last Update
January 29 2021
Active Locations (1)
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1
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10330