Efficacy and Safety of Apixaban in Korean Frail Atrial Fibrillation Patient

NCT05773222 | Active Not Recruiting

• 1 other identifier: ASPIRE study
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Stroke

  up to 12 months

• Systemic embolism

  up to 12 months

• Major bleeding

  ISTH criteria

  up to 12 months

Secondary Outcomes (5)

• Death from any cause

  up to 12 months

• Myocardial infarction

  up to 12 months

• Composite of major bleeding and clinically relevant nonmajor bleeding

  up to 12 months

• Any bleeding

  up to 12 months

• Other adverse events including liver or kidney function abnormalities

  up to 12 months

Interventions

Apixaban DRUG

Single Group Assignment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A. Arm Label: prospective, multicenter, non-interventional observational study B. Arm type: no intervention

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: August 12, 2019
• Primary Completion: March 4, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

KR (1)