Atrial Fibrillation (AF)
Conditions
Keywords
Apixaban,, Rivaroxaban
Brief summary
Patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban) in atrial fibrillation will be conducted a follow-up investigation on systemic embolism and bleeding events.
Detailed description
This study aims to evaluate 1) the efficacy and safety of Factor Xa inhibitors (Apixaban, Rivaroxaban) in atrial fibrillation patients who meet the inclusion criteria, and 2) the relationship between systemic embolism and bleeding by tracking and analyzing echocardiographic data, with the goal of developing an AF-ECHO NOAC Score to predict these events. Additionally, we aim to create a predictive model for thromboembolic and bleeding events by observing the occurrence and progression of mitral and tricuspid regurgitation due to atrial remodeling and annular dilation in atrial fibrillation.
Interventions
None listed
Sponsors
Korea University Anam Hospital
Korea University Ansan Hospital
Mediplex Sejong Hospital
Chungnam National University Hospital
Chonnam National University Hospital
Kyung Hee University Hospital at Gangdong
Kyungpook National University Hospital
Korea University Guro Hospital
InjeUniversityIlsanPaikHospital
Wonkwang University Hospital
Keimyung University Dongsan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients aged 19 years or older with chronic atrial fibrillation, accompanied by at least one of the following conditions: ① Heart failure ② 2. Myocardial infarction (more than 3 months post-event) ③ 3. Angina (if PCI was performed, more than 3 months post-procedure) ④ 4. Hypertension ⑤ 5. Diabetes mellitus 2. Patients who started taking Factor Xa inhibitors (Apixaban, Rivaroxaban) within the last 12 months and have echocardiographic images taken within 3 months of that time, which are available for analysis. 3. Patients who are starting treatment with Factor Xa inhibitors. (Apixaban, Rivaroxaban) 4. Individuals who have voluntarily provided written consent to participate in this clinical trial.
Exclusion criteria
1. Patients with creatinine clearance (CCr) less than 15 ml/min. 2. Patients with moderate to severe mitral stenosis. 3. Patients who have undergone mechanical valve replacement 4. Patients with a history of clinically significant alcohol or drug abuse. 5. Patients whom the investigator deems legally or mentally unsuitable for participation in the clinical trial, or those who do not consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome MeasureIdentification of risk factors for systemic embolism and bleeding through echocardiography in atrial fibrillation patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban) | From enrollment to the end of treatment at 60 months. | We aim to retrospectively and prospectively assess the risk of systemic embolism and bleeding in Korean patients with atrial fibrillation who are taking oral anticoagulants, specifically Factor Xa inhibitors (Apixaban, Rivaroxaban). Additionally, we will evaluate echocardiographic parameters such as ventricular and atrial function, as well as valvular regurgitation, which are expected to influence the occurrence of embolism and bleeding. |
Countries
South Korea
Outcome results
None listed