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)

Active, not recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06779695
• Lead Sponsor: Korea University Anam Hospital

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.

Study Timeline

• Study Start: 2024-04-21
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-16
• Last Update Posted: 2025-01-16
• Primary Completion: 2028-09-30
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of