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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-21

Study Completion Date

2031-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Atrial Fibrillation (AF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No