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)

January 13, 2025 updated by: Seong-Mi Park, M.D. Ph.D., Korea University Anam Hospital
Patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban) in atrial fibrillation will be conducted a follow-up investigation on systemic embolism and bleeding events.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Atrial fibrillation patients from 11 institutions who are taking or starting Factor Xa inhibitors (Apixaban, Rivaroxaban)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Collaborators

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

Investigators

  • Study Chair: Dong-Hyuk Cho, PhD, Korea University Anam Hospital
  • Study Chair: So Ree Kim, PhD, Korea University Anam Hospital
  • Study Chair: Mi-Na Kim, M.D., Ph.D., Korea University Anam Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2024

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024AN0119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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