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NCT Number: NCT05773222

Efficacy and Safety of Apixaban in Korean Frail Atrial Fibrillation Patient

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must be ≥19 years.
  • Patient has non-valvular atrial fibrillation necessitating the use of apixaban for stroke prevention.
  • Subjects satisfies single dose reduction criterion for apixaban; (1) age 80 years or older (2) body weight 60kg or lower (3) serum creatinine 1.5mg/dL or higher.

Exclusion criteria

  • Patient is vulnerable (according to Korean Good Clinical Practice definition) or disagree with the study.
  • Patient had a history of clinical events, defined as primary and secondary outcomes of the study, prior to study registration after taking apixaban.
  • Patient satisfies two or more dose reduction criteria for apixaban.

Treatment and study plan

Apixaban

Drug

Single Group Assignment

Primary outcomes

  1. Stroke

    Time frame: up to 12 months

  2. Systemic embolism

    Time frame: up to 12 months

  3. Major bleeding

    Time frame: up to 12 months

    ISTH criteria

Secondary outcomes

  1. Death from any cause

    Time frame: up to 12 months

  2. Myocardial infarction

    Time frame: up to 12 months

  3. Composite of major bleeding and clinically relevant nonmajor bleeding

    Time frame: up to 12 months

    ISTH criteria

  4. Any bleeding

    Time frame: up to 12 months

  5. Other adverse events including liver or kidney function abnormalities

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The efficAcy and Safety of aPixaban In REal-world Practice in Korean Frail Patients With Atrial Fibrillation: a Prospective Multicenter Non-interventional, Observational Study: ASPIRE Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2026
First posted
Mar 17, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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