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

NCT ID: NCT04747496

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-26

Study Completion Date

2024-11-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NVAF patients

NVAF adult patients with one or more risk factors treated with edoxaban.

Edoxaban

Intervention Type DRUG

This is a non-interventional, observational study.

Interventions

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Edoxaban

This is a non-interventional, observational study.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

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Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University

Beijing, Changping District, China

Site Status

Aviation General Hospital of China Medical University

Beijing, Chaoyang District, China

Site Status

Beijing Anzhen Hospital, Capital Medical University

Beijing, Chaoyang District, China

Site Status

Beijing Chao-Yang Hospital Capital Medical University

Beijing, Chaoyang District, China

Site Status

Beijing Hospital

Beijing, Dongcheng District, China

Site Status

Beijing Tongren Hospital,Cmu

Beijing, Dongcheng District, China

Site Status

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

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Guangzhou First People'S Hospital

Guangzhou, Guangdong, China

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Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Site Status

Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

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The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

The First People'S Hospital of Nanning

Nanjing, Guangxi, China

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The Third People'S Hospital of Nanning

Nanning, Guangxi, China

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Heilongjiang Provincial Hospital

Harbin, Heilongjiang, China

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Kaifeng Central Hospital

Kaifeng, Henan, China

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The Third Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

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Xinxiang Central Hospital

Xinxiang, Henan, China

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The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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Tianjin Medical University General Hospital

Tianjin, Heping District, China

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The Second Hospital of Tianjin Medical University

Tianjin, Hexi District, China

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Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine

Shanghai, Huangpu District, China

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Hebei Petro China Center Hospital

Langfang, Hubei, China

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Dongfeng General Hospital of Chinese Medicine

Shiyan, Hubei, China

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Renmin Hospital of Wuhan University Hubei General Hospital

Wuhan, Hubei, China

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The Central Hospital of Wuhan

Wuhan, Hubei, China

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Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology

Wuhan, Hubei, China

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Union Hospital Affiliated With Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

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Wuhan Puai Hospital

Wuhan, Hubei, China

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Wuhan Third Hospital

Wuhan, Hubei, China

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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Changsha Central Hospital

Changsha, Hunan, China

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Hunan Provincial People'S Hospital

Changsha, Hunan, China

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The First Hospital of Changsha

Changsha, Hunan, China

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The Fourth Hospital of Changsha

Changsha, Hunan, China

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

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Xiangtan Central Hospital

Xiangtan, Hunan, China

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Changzhou No.2 People'S Hospital

Changzhou, Jiangsu, China

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Jiangyin People'S Hospital

Jiangyin, Jiangsu, China

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The First People'S Hospital of Kunshan

Kunshan, Jiangsu, China

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Jiangxi Provincial People'S Hospital

Nanchang, Jiangsu, China

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Nanjing Jiangning Hospital

Nanjing, Jiangsu, China

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The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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The Second People'S Hospital of Suzhou

Suzhou, Jiangsu, China

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Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

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Wuxi People'S Hospital

Wuxi, Jiangsu, China

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

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Xuzhou Central Hospital

Xuzhou, Jiangsu, China

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Jilin Province People'S Hospital

Changchun, Jilin, China

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The Fourth Hospital of Jilin University

Changchun, Jilin, China

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The Second Hospital of Jilin University

Changchun, Jilin, China

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The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

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China Shenyang Chest Hospital

Shenyang, Liaoning, China

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The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China

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Beijing Miyun District Hospital

Beijing, Minyun District, China

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Shanghai East Hospital,Tongji University

Shanghai, Pudong New Area, China

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Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

Shanghai, Qingpu District, China

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The Fifth People'S Hospital of Jinan

Jinan, Shandong, China

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Affiliated Hospital of Weifang Medical University

Weifang, Shandong, China

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Hangzhou Third Hospital

Hangzhou, Shangcheng District, China

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Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

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Shanxi Bethune Hospital

Taiyuan, Shanxi, China

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Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

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Shanxi Provincial People'S Hospital

Taiyuan, Shanxi, China

Site Status

Taiyuan Central Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Beijing Chest Hospital, Capital Medical University

Beijing, Tongzhou District, China

Site Status

Peking Union Medical College Hospital

Beijing, Xicheng District, China

Site Status

Peking University First Hospital

Beijing, Xicheng District, China

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The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

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Xuanwu Hospital Capital Medical University

Beijing, Xuanwu District, China

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Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Xuhui District, China

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Shanghai Yangpu East Hospital

Shanghai, Yangpu District, China

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The First Hospital of Kunming

Kunming, Yunnan, China

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Chongqing General Hospital

Chongqing, Yuzhong District, China

Site Status

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Yuzhong District, China

Site Status

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Yuzhong District, China

Site Status

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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Zhejiang Greentown Cardiovascular Hospital

Hangzhou, Zhejiang, China

Site Status

Zhejiang Hospital

Hangzhou, Zhejiang, China

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Zhejiang Provincial Hospital of Chinese Medicine

Hangzhou, Zhejiang, China

Site Status

Zhejiang Provincial People'S Hospital

Hangzhou, Zhejiang, China

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The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

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The Second Hospital of Jiaxing

Jiaxing, Zhejiang, China

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Ningbo First Hospital

Ningbo, Zhejiang, China

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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Wenzhou Central Hospital

Wenzhou, Zhejiang, China

Site Status

Wenzhou Hospital of Traditional Chinese Medicine

Wenzhou, Zhejiang, China

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Wenzhou People'S Hospital

Wenzhou, Zhejiang, China

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Beijing Chao-Yang Hospital Capital Medical University

Beijing, , China

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Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital

Beijing, , China

Site Status

The Fourth Hospital of Changhsa

Changsha, , China

Site Status

Countries

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China

Other Identifiers

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DSCN-ETNA AF-RWS-001

Identifier Type: -

Identifier Source: org_study_id

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