Clinical trial NCT06779695: Prediction of Systemic Thromboembolism and Bleeding in Atrial Fibrillation Patients With Factor Xa Inhibitor (Apixaban, Rivaroxaban) by Echocardiographic Parameters: Prospective Observational Study (AF-ECHO Study)
Official title: Prediction of Systemic Thromboembolism and Bleeding in Atrial Fibrillation Patients With Factor Xa Inhibitor (Apixaban, Rivaroxaban) by Echocardiographic Parameters: Prospective Observational Study (AF-ECHO Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Apixaban,
Rivaroxaban
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Korea University Ansan Hospital
name: Mediplex Sejong Hospital
name: Chungnam National University Hospital
name: Chonnam National University Hospital
name: Kyung Hee University Hospital at Gangdong
name: Kyungpook National University Hospital
name: Korea University Guro Hospital
name: InjeUniversityIlsanPaikHospital
name: Wonkwang University Hospital
name: Keimyung University Dongsan Medical Center
First posted: 2025-01-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial fibrillation patients from 11 institutions who are taking or starting Factor Xa inhibitors (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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Outcome MeasureIdentification of risk factors for systemic embolism and bleeding through echocardiography in atrial fibrillation patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban)
timeFrame: From enrollment to the end of treatment at 60 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Mi-Na Kim, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Korea University Anam Hospital
name: Dong-Hyuk Cho, PhD
role: STUDY_CHAIR
affiliation: Korea University Anam Hospital
name: So Ree Kim, PhD
role: STUDY_CHAIR
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