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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05773222
Other study ID # ASPIRE study
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 12, 2019
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2500
Est. completion date December 31, 2024
Est. primary completion date March 4, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apixaban
Single Group Assignment

Locations

Country Name City State
Korea, Republic of Seoul National university Hostpital Seoul Jongno-gu

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stroke up to 12 months
Primary Systemic embolism up to 12 months
Primary Major bleeding ISTH criteria up to 12 months
Secondary Death from any cause up to 12 months
Secondary Myocardial infarction up to 12 months
Secondary Composite of major bleeding and clinically relevant nonmajor bleeding ISTH criteria up to 12 months
Secondary Any bleeding up to 12 months
Secondary Other adverse events including liver or kidney function abnormalities up to 12 months
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