An observational study in Atrial Fibrillation, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Seoul National University Hospital · Observational
Atrial fibrillation (AF) is the most common arrhythmia, and its prevalence is increasing with the aging population [1]. As the prevalence of AF is significantly rising among the population over 70-80 years old and considering the population is at high risk of AF complications such as stroke, oral anticoagulation (OAC) therapy is necessary among these subjects [1-3]. OAC decreases the risk of stroke and systemic thromboembolism with improved mortality among AF patients. The introduction of non-vitamin K antagonist oral anticoagulants (NOAC) has led to more effective and safe anticoagulation therapy among Asian patients [4,5]. Among different types of NOAC, the prescription of apixaban has been increasing based on robust safety data. The ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), phase three clinical trial on apixaban., showed efficacy and safety of apixaban compared to warfarin among 18,000 patients worldwide [6]. However, this study only included 5.5% (986) Asian patients.
Of patients requiring OAC, those of old age, low body weight, or decreased renal function are at 'high risk' of stroke, systemic thromboembolism, and major bleeding events [4, 7-9]. In Korea, among patients prescribed with NOAC due to AF, 35-40% were older than the age of 75 years old, 35% had bodyweight ≤ 60kg and 25-30% had decreased renal function (Creatinine clearance ≤ 60ml/min) [10]. Although apixaban has proved safe in old age, low bodyweight decreased renal function in ARISTOTLE subgroup analyses, the efficacy and safety data on Asian AF patients with high-risk factors is limited [11-14].
In this study, the investigators aimed to evaluate the efficacy and safety of apixaban among high-risk Korean patients in old age, low bodyweight or decreased renal function using a multicenter observational study design
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 2,002 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
A. Arm Label: prospective, multicenter, non-interventional observational study B. Arm type: no intervention
Exclusion Criteria:
Single Group Assignment
Stroke
Time frame: up to 12 months
Systemic embolism
Time frame: up to 12 months
Major bleeding
ISTH criteria
Time frame: up to 12 months
Death from any cause
Time frame: up to 12 months
Myocardial infarction
Time frame: up to 12 months
Composite of major bleeding and clinically relevant nonmajor bleeding
ISTH criteria
Time frame: up to 12 months
Any bleeding
Time frame: up to 12 months
Other adverse events including liver or kidney function abnormalities
Time frame: up to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital