Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China
ETNA-AF-CHINA
1 other identifier
observational
5,000
1 country
97
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2021
Typical duration for all trials
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2024
CompletedJanuary 9, 2025
January 1, 2025
3.8 years
February 5, 2021
January 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (1)
NVAF patients
NVAF adult patients with one or more risk factors treated with edoxaban.
Interventions
Eligibility Criteria
Patients with NVAF treated with edoxaban will be enrolled in this non-interventional, observational study.
You may qualify if:
- 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
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Daiichi Sankyo Co., Ltd.collaborator
Study Sites (97)
Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
Beijing, Changping 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
Beijing, Chaoyang District, China
Beijing Hospital
Beijing, Dongcheng District, China
Beijing Tongren Hospital,Cmu
Beijing, Dongcheng District, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Second Provincial General Hospital
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
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan 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
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First People'S Hospital of Nanning
Nanjing, Guangxi, China
The Third People'S Hospital of Nanning
Nanning, Guangxi, China
Heilongjiang Provincial Hospital
Harbin, Heilongjiang, China
Kaifeng Central Hospital
Kaifeng, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tianjin Medical University General Hospital
Tianjin, Heping District, China
The Second Hospital of Tianjin Medical University
Tianjin, Hexi District, China
Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Huangpu District, China
Hebei Petro China Center Hospital
Langfang, Hubei, China
Dongfeng General Hospital of Chinese Medicine
Shiyan, Hubei, China
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
Union Hospital Affiliated With Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Puai Hospital
Wuhan, Hubei, China
Wuhan Third Hospital
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
Hunan Provincial People'S Hospital
Changsha, Hunan, China
The First Hospital of Changsha
Changsha, Hunan, China
The Fourth Hospital of Changsha
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Changzhou No.2 People'S Hospital
Changzhou, Jiangsu, China
Jiangyin People'S Hospital
Jiangyin, Jiangsu, China
The First People'S Hospital of Kunshan
Kunshan, Jiangsu, China
Jiangxi Provincial People'S Hospital
Nanchang, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Second People'S Hospital of Suzhou
Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Wuxi People'S Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jilin Province People'S Hospital
Changchun, Jilin, China
The Fourth Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
China Shenyang Chest Hospital
Shenyang, Liaoning, China
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China
Beijing Miyun District Hospital
Beijing, Minyun District, China
Shanghai East Hospital,Tongji University
Shanghai, Pudong New Area, China
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
Shanghai, Qingpu District, China
The Fifth People'S Hospital of Jinan
Jinan, Shandong, China
Affiliated Hospital of Weifang Medical University
Weifang, Shandong, China
Hangzhou Third Hospital
Hangzhou, Shangcheng District, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People'S Hospital
Taiyuan, Shanxi, China
Taiyuan Central Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Beijing Chest Hospital, Capital Medical University
Beijing, Tongzhou District, China
Peking Union Medical College Hospital
Beijing, Xicheng District, China
Peking University First Hospital
Beijing, Xicheng District, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Xuanwu Hospital Capital Medical University
Beijing, Xuanwu District, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Xuhui District, China
Shanghai Yangpu East Hospital
Shanghai, Yangpu District, China
The First Hospital of Kunming
Kunming, Yunnan, 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
Chongqing, Yuzhong District, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Greentown Cardiovascular Hospital
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of Chinese Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang, China
Wenzhou People'S Hospital
Wenzhou, Zhejiang, China
Beijing Chao-Yang Hospital Capital Medical University
Beijing, China
Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital
Beijing, China
The Fourth Hospital of Changhsa
Changsha, China
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
February 10, 2021
Study Start
February 26, 2021
Primary Completion
November 27, 2024
Study Completion
November 27, 2024
Last Updated
January 9, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
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/