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)

NCT06779695 | Active Not Recruiting DMC

• 1 other identifier: 2024AN0119
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Apixaban,; Rivaroxaban

Outcome Measures

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)

  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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Related Publications (8)

• 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.

  PMID: 36871530 RESULT

• 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.

  PMID: 27742243 RESULT

• 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.

  PMID: 32787500 RESULT

• 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.

  PMID: 29273635 RESULT

• 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.

  PMID: 29747837 RESULT

• 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.

  PMID: 30834802 RESULT

• 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.

  PMID: 28082528 RESULT

• 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.

  PMID: 30613418 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mi-Na Kim, M.D., Ph.D.

  Korea University Anam Hospital

  STUDY CHAIR

• Dong-Hyuk Cho, PhD

  Korea University Anam Hospital

  STUDY CHAIR

• So Ree Kim, PhD

  Korea University Anam Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 16, 2025
• Study Start: April 21, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)