Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China (ETNA-AF-CHINA)

Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China

The safety of edoxaban treatment will be examined using real-world clinical evidence from adult patients with non-valvular atrial fibrillation (NVAF) indications in routine clinical practice.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-valvular Atrial Fibrillation
• Intervention / Treatment: Drug: Edoxaban

Detailed Description

This non-interventional, observational study will evaluate the safety of edoxaban treatment in adult patients with NVAF indications with one or more risk factors.

The primary objective of the study is to collect and evaluate safety data up to 2 years in a real-world setting in relation to adverse event onset (related to edoxaban treatment), duration, severity, and outcome.

The secondary objective will evaluate the effect of edoxaban treatment on stroke (ischemic and hemorrhagic), systemic embolic event (SEE), transient ischemic attack (TIA), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), acute coronary syndrome (ACS), hospitalization related to cardiovascular condition, extent of exposure and compliance to edoxaban therapy, and rate and reasons of permanent discontinuation of edoxaban therapy.

• Study Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Chao-Yang Hospital Capital Medical University
  • Beijing, China
    • Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital
  • Changsha, China
    • The Fourth Hospital of Changhsa
  • Changping District
    • Beijing, Changping District, China
      • Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
  • Chaoyang District
    • Beijing, Chaoyang District, China
      • Aviation General Hospital of China Medical University
    • Beijing, Chaoyang District, China
      • Beijing Anzhen Hospital, Capital Medical University
    • Beijing, Chaoyang District, China
      • Beijing Chao-Yang Hospital Capital Medical University
  • Dongcheng District
    • Beijing, Dongcheng District, China
      • Beijing Hospital
    • Beijing, Dongcheng District, China
      • Beijing Tongren Hospital,Cmu
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • the Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China
      • Guangzhou Panyu Central Hospital
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Zhujiang hospital of southern medical university
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
    • Guangzhou, Guangdong, China
      • Guangdong Second Provincial General Hospital
  • Guangxi Province
    • Nanjing, Guangxi Province, China
      • The First People's Hospital of Nanning
    • Nanning, Guangxi Province, China
      • The Third People'S Hospital of Nanning
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Heilongjiang provincial hospital
  • Henan
    • Kaifeng, Henan, China
      • Kaifeng Central Hospital
    • Xinxiang, Henan, China
      • The Third Affiliated Hospital of Xinxiang Medical University
    • Xinxiang, Henan, China
      • Xinxiang Central Hospital
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • The fifth Affiliated Hospital of Zhengzhou University
  • Heping District
    • Tianjin, Heping District, China
      • Tianjin Medical University General Hospital
  • Hexi District
    • Tianjin, Hexi District, China
      • The Second Hospital of Tianjin Medical University
  • Huangpu District
    • Shanghai, Huangpu District, China
      • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
  • Hubei
    • Langfang, Hubei, China
      • Hebei Petro China Center Hospital
    • Shiyan, Hubei, China
      • Dongfeng General Hospital of Chinese Medicine
    • Wuhan, Hubei, China
      • The Central Hospital Of Wuhan
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Wuhan Third Hospital
    • Wuhan, Hubei, China
      • Wuhan Puai Hospital
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University Hubei General Hospital
    • Wuhan, Hubei, China
      • Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Hunan Provincial People's Hospital
    • Changsha, Hunan, China
      • The First Hospital of Changsha
    • Changsha, Hunan, China
      • Changsha Central Hospital
    • Changsha, Hunan, China
      • The Fourth Hospital of Changsha
    • Xiangtan, Hunan, China
      • Xiangtan Central Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Changzhou No.2 People's Hospital
    • Jiangyin, Jiangsu, China
      • Jiangyin People's Hospital
    • Kunshan, Jiangsu, China
      • The First People'S Hospital of Kunshan
    • Nanchang, Jiangsu, China
      • Jiangxi Provincial People's Hospital
    • Nanjing, Jiangsu, China
      • Nanjing Jiangning Hospital
    • Nanjing, Jiangsu, China
      • The Second Affiliated Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China
      • The Second People'S Hospital of Suzhou
    • Wuxi, Jiangsu, China
      • Affiliated Hospital of Jiangnan University
    • Wuxi, Jiangsu, China
      • Wuxi People's Hospital
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University
    • Xuzhou, Jiangsu, China
      • Xuzhou Central Hospital
  • Jilin
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University
    • Changchun, Jilin, China
      • Jilin Province People's Hospital
    • Changchun, Jilin, China
      • The Fourth Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China
      • The Second Affiliated Hospital of Shenyang Medical College
    • Shenyang, Liaoning, China
      • China Shenyang Chest Hospital
  • Minyun District
    • Beijing, Minyun District, China
      • Beijing miyun district hospital
  • Pudong New Area
    • Shanghai, Pudong New Area, China
      • Shanghai East Hospital,Tongji University
  • Qingpu District
    • Shanghai, Qingpu District, China
      • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
  • Shandong
    • Jinan, Shandong, China
      • The Fifth People's Hospital of Jinan
    • Weifang, Shandong, China
      • Affiliated hospital of Weifang Medical University
  • Shangcheng District
    • Hangzhou, Shangcheng District, China
      • Hangzhou Third Hospital
  • Shanxi
    • Changzhi, Shanxi, China
      • Heping Hospital Affiliated to Changzhi Medical College
    • Taiyuan, Shanxi, China
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital
    • Taiyuan, Shanxi, China
      • Taiyuan Central Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
  • Tongzhou District
    • Beijing, Tongzhou District, China
      • Beijing Chest Hospital, Capital Medical University
  • Xicheng District
    • Beijing, Xicheng District, China
      • Peking Union Medical College Hospital
    • Beijing, Xicheng District, China
      • Peking University First Hospital
  • Xinjiang Province
    • Ürümqi, Xinjiang Province, China
      • The first affiliated hospital of Xinjiang Medical University
  • Xuanwu District
    • Beijing, Xuanwu District, China
      • Xuanwu Hospital Capital Medical University
  • Xuhui District
    • Shanghai, Xuhui District, China
      • Longhua Hospital Shanghai University of Traditional Chinese Medicine
  • Yangpu District
    • Shanghai, Yangpu District, China
      • Shanghai Yangpu East Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The First Hospital of Kunming
  • Yuzhong District
    • Chongqing, Yuzhong District, China
      • Chongqing General Hospital
    • Chongqing, Yuzhong District, China
      • The First Affiliated Hospital of Chongqing Medical University
    • Chongqing, Yuzhong District, China
      • The Second Affiliated Hospital of Chongqing Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial Hospital of Chinese Medicine
    • Hangzhou, Zhejiang, China
      • Zhejiang Greentown Cardiovascular Hospital
    • Jiaxing, Zhejiang, China
      • The First hospital of Jiaxing
    • Jiaxing, Zhejiang, China
      • The second Hospital of Jiaxing
    • Ningbo, Zhejiang, China
      • Ningbo First Hospital
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China
      • Wenzhou Hospital of Traditional Chinese Medicine
    • Wenzhou, Zhejiang, China
      • Wenzhou Central Hospital
    • Wenzhou, Zhejiang, China
      • Wenzhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with NVAF treated with edoxaban will be enrolled in this non-interventional, observational study.

Description

Inclusion Criteria:

• Written, informed consent
• NVAF-patients treated with edoxaban according to packaging information (i.e., for NVAF adult patients with one or more risk factors (such as history of congestive heart failure, hypertension, age ≥75 years old, diabetes, prior stroke or TIA) in prevention of stroke and systemic circulation embolism)
• Not participating in any interventional study at the same time

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NVAF patients; NVAF adult patients with one or more risk factors treated with edoxaban.	Drug: Edoxaban; This is a non-interventional, observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment	Baseline up to 2 years post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment	Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment	Baseline up to 2 years post treatment
Duration of exposure to edoxaban treatment in NVAF patients	Baseline up to 2 years post treatment
Compliance rate of edoxaban treatment in NVAF patients	Baseline up to 2 years post treatment
Proportion of participants who discontinued edoxaban treatment in NVAF patients	Baseline up to 2 years post treatment
Number of interventions related to atrial fibrillation/edoxaban in NVAF patients	Baseline up to 2 years post treatment

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Collaborators: Daiichi Sankyo (China) Holdings Co., Ltd.
• Investigators: Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Estimated): October 27, 2024
• Study Completion (Estimated): October 27, 2024

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Non-valvular atrial fibrillation; Edoxaban
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: DSCN-ETNA AF-RWS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No