Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China
- Registration Number
- NCT04747496
- Lead Sponsor
- Daiichi Sankyo
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
- 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 β₯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
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NVAF patients Edoxaban NVAF adult patients with one or more risk factors treated with edoxaban.
- Primary Outcome Measures
Name Time Method 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 major bleeding events 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
Name Time Method Proportion of participants who discontinued edoxaban treatment in NVAF patients 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 Duration of exposure to edoxaban treatment in NVAF patients Baseline up to 2 years post treatment 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 venous thromboembolism (VTE) following edoxaban treatment 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 Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition 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 acute coronary syndrome (ACS) following edoxaban treatment Baseline up to 2 years post treatment Compliance rate of edoxaban treatment in NVAF patients Baseline up to 2 years post treatment
Trial Locations
- Locations (96)
The First Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Changzhou No.2 People'S Hospital
π¨π³Changzhou, Jiangsu, China
Taiyuan Central Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
West China Hospital, Sichuan University
π¨π³Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University
π¨π³Wenzhou, Zhejiang, China
Dongfeng General Hospital of Chinese Medicine
π¨π³Shiyan, Hubei, China
Aviation General Hospital of China Medical University
π¨π³Beijing, Chaoyang District, China
Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
π¨π³Beijing, Changping District, China
Beijing Anzhen Hospital, Capital Medical University
π¨π³Beijing, Chaoyang District, China
Beijing Chao-Yang Hospital Capital Medical University
π¨π³Beijing, China
Beijing Hospital
π¨π³Beijing, Dongcheng District, China
Beijing Tongren Hospital,Cmu
π¨π³Beijing, Dongcheng District, China
The First Hospital of Lanzhou University
π¨π³Lanzhou, Gansu, China
Guangdong Second Provincial General Hospital
π¨π³Guangzhou, Guangdong, China
Guangzhou First People'S Hospital
π¨π³Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
π¨π³Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
π¨π³Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
The First People'S Hospital of Nanning
π¨π³Nanjing, Guangxi Province, China
The Third People'S Hospital of Nanning
π¨π³Nanning, Guangxi Province, China
Zhujiang Hospital of Southern Medical University
π¨π³Guangzhou, Guangdong, China
Heilongjiang Provincial Hospital
π¨π³Harbin, Heilongjiang, China
Kaifeng Central Hospital
π¨π³Kaifeng, Henan, China
The Third Affiliated Hospital of Xinxiang Medical University
π¨π³Xinxiang, Henan, China
Xinxiang Central Hospital
π¨π³Xinxiang, Henan, China
The Fifth Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
The Second Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine
π¨π³Shanghai, Huangpu District, China
Tianjin Medical University General Hospital
π¨π³Tianjin, Heping District, China
The Second Hospital of Tianjin Medical University
π¨π³Tianjin, Hexi District, China
Hebei Petro China Center Hospital
π¨π³Langfang, Hubei, China
Renmin Hospital of Wuhan University Hubei General Hospital
π¨π³Wuhan, Hubei, China
The Central Hospital of Wuhan
π¨π³Wuhan, Hubei, China
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
π¨π³Wuhan, Hubei, China
Union Hospital Affiliated With Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Wuhan Puai Hospital
π¨π³Wuhan, Hubei, China
Wuhan Third Hospital
π¨π³Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
π¨π³Wuhan, Hubei, China
Changsha Central Hospital
π¨π³Changsha, Hunan, China
The Fourth Hospital of Changsha
π¨π³Changsha, Hunan, China
The First Hospital of Changsha
π¨π³Changsha, Hunan, China
Hunan Provincial People'S Hospital
π¨π³Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
π¨π³Changsha, Hunan, China
Xiangtan Central Hospital
π¨π³Xiangtan, Hunan, China
The First People'S Hospital of Kunshan
π¨π³Kunshan, Jiangsu, China
Jiangyin People'S Hospital
π¨π³Jiangyin, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
π¨π³Nanjing, Jiangsu, China
Jiangxi Provincial People'S Hospital
π¨π³Nanchang, Jiangsu, China
Nanjing Jiangning Hospital
π¨π³Nanjing, Jiangsu, China
The Second People'S Hospital of Suzhou
π¨π³Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
π¨π³Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
π¨π³Xuzhou, Jiangsu, China
Wuxi People'S Hospital
π¨π³Wuxi, Jiangsu, China
Xuzhou Central Hospital
π¨π³Xuzhou, Jiangsu, China
The Fourth Hospital of Jilin University
π¨π³Changchun, Jilin, China
Jilin Province People'S Hospital
π¨π³Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
The Second Hospital of Jilin University
π¨π³Changchun, Jilin, China
China Shenyang Chest Hospital
π¨π³Shenyang, Liaoning, China
Beijing Miyun District Hospital
π¨π³Beijing, Minyun District, China
The Second Affiliated Hospital of Shenyang Medical College
π¨π³Shenyang, Liaoning, China
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
π¨π³Shanghai, Qingpu District, China
Shanghai East Hospital,Tongji University
π¨π³Shanghai, Pudong New Area, China
Affiliated Hospital of Weifang Medical University
π¨π³Weifang, Shandong, China
The Fifth People'S Hospital of Jinan
π¨π³Jinan, Shandong, China
Hangzhou Third Hospital
π¨π³Hangzhou, Shangcheng District, China
Heping Hospital Affiliated to Changzhi Medical College
π¨π³Changzhi, Shanxi, China
Shanxi Bethune Hospital
π¨π³Taiyuan, Shanxi, China
Shanxi Cardiovascular Hospital
π¨π³Taiyuan, Shanxi, China
Shanxi Provincial People'S Hospital
π¨π³Taiyuan, Shanxi, China
Beijing Chest Hospital, Capital Medical University
π¨π³Beijing, Tongzhou District, China
Peking Union Medical College Hospital
π¨π³Beijing, Xicheng District, China
The First Affiliated Hospital of Xinjiang Medical University
π¨π³ΓrΓΌmqi, Xinjiang Province, China
Xuanwu Hospital Capital Medical University
π¨π³Beijing, Xuanwu District, China
Shanghai Yangpu East Hospital
π¨π³Shanghai, Yangpu District, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
π¨π³Shanghai, Xuhui District, China
The First Hospital of Kunming
π¨π³Kunming, Yunnan, China
The Second Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, Yuzhong District, China
Chongqing General Hospital
π¨π³Chongqing, Yuzhong District, China
The First Affiliated Hospital of Chongqing Medical University
π¨π³Chongqing, Yuzhong District, China
Zhejiang Greentown Cardiovascular Hospital
π¨π³Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of Chinese Medicine
π¨π³Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Zhejiang Hospital
π¨π³Hangzhou, Zhejiang, China
Zhejiang Provincial People'S Hospital
π¨π³Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
π¨π³Jiaxing, Zhejiang, China
The Second Hospital of Jiaxing
π¨π³Jiaxing, Zhejiang, China
Ningbo First Hospital
π¨π³Ningbo, Zhejiang, China
Wenzhou Central Hospital
π¨π³Wenzhou, Zhejiang, China
Wenzhou Hospital of Traditional Chinese Medicine
π¨π³Wenzhou, Zhejiang, China
Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital
π¨π³Beijing, China
Wenzhou People'S Hospital
π¨π³Wenzhou, Zhejiang, China
The Fourth Hospital of Changhsa
π¨π³Changsha, China
Peking University First Hospital
π¨π³Beijing, Xicheng District, China