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Efficacy and Safety of Apixaban in Korean Frail Atrial Fibrillation Patient

NCT05773222 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2025-05-16

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Apixaban

Single Group Assignment

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2022-03-04
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773222 on ClinicalTrials.gov