Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773222
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-03-06
Brief Title:
Efficacy and Safety of Apixaban in Korean Frail Atrial Fibrillation Patient
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 45 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 18000 patients worldwide 6 However this study only included 55 986 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 60mlmin 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
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 60mlmin 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None