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NCT Number: 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)

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.
  • Patients who are starting treatment with Factor Xa inhibitors. (Apixaban, Rivaroxaban)
  • Individuals who have voluntarily provided written consent to participate in this clinical trial.

Exclusion criteria

  • Patients with creatinine clearance (CCr) less than 15 ml/min.
  • Patients with moderate to severe mitral stenosis.
  • Patients who have undergone mechanical valve replacement
  • Patients with a history of clinically significant alcohol or drug abuse.
  • 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.

Treatment and study plan

Primary outcomes

  1. Primary Outcome MeasureIdentification of risk factors for systemic embolism and bleeding through echocardiography in atrial fibrillation patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Chonnam National University Hospital
  • Chungnam National University Hospital
  • InjeUniversityIlsanPaikHospital
  • Keimyung University Dongsan Medical Center
  • Korea University Ansan Hospital
  • Korea University Guro Hospital
  • Kyung Hee University Hospital at Gangdong
  • Kyungpook National University Hospital
  • Mediplex Sejong Hospital
  • Wonkwang University Hospital

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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