Clinical trial NCT05773222: Efficacy and Safety of Apixaban in Korean Frail Atrial Fibrillation Patient
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 2500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A. Arm Label: prospective, multicenter, non-interventional observational study B. Arm type: no intervention

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


Eligibility criteria: Inclusion Criteria:

1. Patient must be ≥19 years.
2. Patient has non-valvular atrial fibrillation necessitating the use of apixaban for stroke prevention.
3. 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:

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

Primary outcomes:
measure: Stroke
timeFrame: up to 12 months
measure: Systemic embolism
timeFrame: up to 12 months
measure: Major bleeding
timeFrame: up to 12 months
Secondary outcomes:
measure: Death from any cause
timeFrame: up to 12 months
measure: Myocardial infarction
timeFrame: up to 12 months
measure: Composite of major bleeding and clinically relevant nonmajor bleeding
timeFrame: up to 12 months
measure: Any bleeding
timeFrame: up to 12 months
measure: Other adverse events including liver or kidney function abnormalities
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National university Hostpital
state: Jongno-gu
Study officials:
References: