AzTrials
AzTrials

Atrial Fibrillation (AF)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)

An observational study of Atrial Fibrillation (AF), run by Korea University Anam Hospital at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Atrial Fibrillation (AF)
How many people
2,000 participants
Where
1 siteSouth Korea
Study dates
21 Apr 2024to 31 Dec 2031
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Anam Hospital

    Seoul, 02841

Other trials in South Korea

About this study

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

Read the 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.

Keywords
Apixaban,, Rivaroxaban
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06779695
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: From enrollment to the end of treatment at 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2025
  2. Study start21 Apr 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06779695
Sponsor's protocol ID
2024AN0119
Status last verified
Jan 2025
First submitted
13 Jan 2025
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yao Y, Zhang Z, Xue J, Chen Z, Zhou Y, Luo W, Ye F, Wang J, Long D. Echocardiographic Mitral Annular Calcification is Associated With Atrial Fibrillation Recurrence After Catheter Ablation. Am J Cardiol. 2023 Apr 15;193:55-60. doi: 10.1016/j.amjcard.2023.01.054. Epub 2023 Mar 3.

    PubMed 36871530

  • Lu ML, Gupta S, Romero-Corral A, Matejkova M, De Venecia T, Obasare E, Bhalla V, Pressman GS. Cardiac Calcifications on Echocardiography Are Associated with Mortality and Stroke. J Am Soc Echocardiogr. 2016 Dec;29(12):1171-1178. doi: 10.1016/j.echo.2016.08.020. Epub 2016 Oct 11.

    PubMed 27742243

  • Liao JN, Chao TF, Kuo JY, Sung KT, Tsai JP, Lo CI, Lai YH, Su CH, Hung CL, Yeh HI. Global Left Atrial Longitudinal Strain Using 3-Beat Method Improves Risk Prediction of Stroke Over Conventional Echocardiography in Atrial Fibrillation. Circ Cardiovasc Imaging. 2020 Aug;13(8):e010287. doi: 10.1161/CIRCIMAGING.119.010287. Epub 2020 Aug 13.

    PubMed 32787500

  • Thomas KL, Jackson LR 2nd, Shrader P, Ansell J, Fonarow GC, Gersh B, Kowey PR, Mahaffey KW, Singer DE, Thomas L, Piccini JP, Peterson ED. Prevalence, Characteristics, and Outcomes of Valvular Heart Disease in Patients With Atrial Fibrillation: Insights From the ORBIT-AF (Outcomes Registry for Better Informed Treatment for Atrial Fibrillation). J Am Heart Assoc. 2017 Dec 22;6(12):e006475. doi: 10.1161/JAHA.117.006475.

    PubMed 29273635

  • Qamar A, Vaduganathan M, Greenberger NJ, Giugliano RP. Oral Anticoagulation in Patients With Liver Disease. J Am Coll Cardiol. 2018 May 15;71(19):2162-2175. doi: 10.1016/j.jacc.2018.03.023.

    PubMed 29747837

  • Lee HF, Chan YH, Chang SH, Tu HT, Chen SW, Yeh YH, Wu LS, Kuo CF, Kuo CT, See LC. Effectiveness and Safety of Non-Vitamin K Antagonist Oral Anticoagulant and Warfarin in Cirrhotic Patients With Nonvalvular Atrial Fibrillation. J Am Heart Assoc. 2019 Mar 5;8(5):e011112. doi: 10.1161/JAHA.118.011112.

    PubMed 30834802

  • Chatterjee NA, Shah RV, Murthy VL, Praestgaard A, Shah SJ, Ventetuolo CE, Barr RG, Kronmal R, Lima JA, Bluemke DA, Jerosch-Herold M, Alonso A, Kawut SM. Right Ventricular Structure and Function Are Associated With Incident Atrial Fibrillation: MESA-RV Study (Multi-Ethnic Study of Atherosclerosis-Right Ventricle). Circ Arrhythm Electrophysiol. 2017 Jan;10(1):e004738. doi: 10.1161/CIRCEP.116.004738.

    PubMed 28082528

  • Rutherford OW, Jonasson C, Ghanima W, Holst R, Halvorsen S. New score for assessing bleeding risk in patients with atrial fibrillation treated with NOACs. Open Heart. 2018 Dec 9;5(2):e000931. doi: 10.1136/openhrt-2018-000931. eCollection 2018.

    PubMed 30613418

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF), run by Korea University Anam Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06779695, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in