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)

Korea University

Status: Active, not recruiting

Conditions: Atrial Fibrillation (AF)

Study type: Observational

Funder types: Other

Identifiers

NCT06779695

2024AN0119

Details and patient eligibility

About

Patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban) in atrial fibrillation will be conducted a follow-up investigation on systemic embolism and bleeding events.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,000 participants in 1 patient group

Patients with chronic AF who have started taking Factor Xa inhibitors.

Description:

Patients aged 19 and over with chronic atrial fibrillation who have started taking Factor Xa inhibitors (Apixaban, Rivaroxaban), within the last 12 months and have obtained an echocardiography image that can be analyzed within 3 months.