The Plasma Level of Branded Generic Apixaban in Patients with Atrial Fibrillatio
Phase 4
Completed
- Conditions
- Atrial fibrillationgeneric apixabanefficiencyanti-factorXa activityAtrial fibrillation (AF)
- Registration Number
- TCTR20230410004
- Lead Sponsor
- Faculty of Medicine, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Adults aged > 20 years with clinical AF who are eligible for DOAC according to latest clinical practice guidelines.
Exclusion Criteria
(1) Received another DOAC before this study
(2) Moderate and severe mitral valve stenosis
(3) Underwent mechanical valve replacement
(4) Estimated glomerular filtration rate (eGFR) by Cockcroft-Gault formula less than 15 ml/min/1.73m2, or CKD stage V / end-stage kidney disease (ESKD)
(5) Chronic liver disease with Child-Turcotte-Pugh score 7 points or higher
(6) Pregnancy or breastfeeding
(7) Poor adherence to medications
(8) Inability to perform proper self-care
(9) Inability to provide an informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-factorXa activity Pre-dose Anti-factorXa level,Anti-factorXa activity Post dose between 2-4 hours Anti-factorXa level
- Secondary Outcome Measures
Name Time Method Ischemic stroke 1 year Number of ischemic stroke event