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 ≥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
🇨🇳Guangzhou, Guangdong, China
Changzhou No.2 People'S Hospital
🇨🇳Changzhou, Jiangsu, China
Taiyuan Central Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Dongfeng General Hospital of Chinese Medicine
🇨🇳Shiyan, Hubei, China
Aviation General Hospital of China Medical University
🇨🇳Beijing, Chaoyang District, China
Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
🇨🇳Beijing, Changping District, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, Chaoyang District, China
Beijing Chao-Yang Hospital Capital Medical University
🇨🇳Beijing, 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 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
The First People'S Hospital of Nanning
🇨🇳Nanjing, Guangxi Province, China
The Third People'S Hospital of Nanning
🇨🇳Nanning, Guangxi Province, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, 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
Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Huangpu District, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Heping District, China
The Second Hospital of Tianjin Medical University
🇨🇳Tianjin, Hexi District, China
Hebei Petro China Center Hospital
🇨🇳Langfang, 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
The Fourth Hospital of Changsha
🇨🇳Changsha, Hunan, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
Hunan Provincial People'S Hospital
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangtan Central Hospital
🇨🇳Xiangtan, Hunan, China
The First People'S Hospital of Kunshan
🇨🇳Kunshan, Jiangsu, China
Jiangyin People'S Hospital
🇨🇳Jiangyin, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Jiangxi Provincial People'S Hospital
🇨🇳Nanchang, Jiangsu, China
Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
The Second People'S Hospital of Suzhou
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Wuxi People'S Hospital
🇨🇳Wuxi, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
The Fourth Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Jilin Province People'S Hospital
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
China Shenyang Chest Hospital
🇨🇳Shenyang, Liaoning, China
Beijing Miyun District Hospital
🇨🇳Beijing, Minyun District, China
The Second Affiliated Hospital of Shenyang Medical College
🇨🇳Shenyang, Liaoning, China
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Qingpu District, China
Shanghai East Hospital,Tongji University
🇨🇳Shanghai, Pudong New Area, China
Affiliated Hospital of Weifang Medical University
🇨🇳Weifang, Shandong, China
The Fifth People'S Hospital of Jinan
🇨🇳Jinan, 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
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 Province, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Xuanwu District, China
Shanghai Yangpu East Hospital
🇨🇳Shanghai, Yangpu District, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Xuhui District, China
The First Hospital of Kunming
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Yuzhong District, China
Chongqing General Hospital
🇨🇳Chongqing, Yuzhong District, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Yuzhong District, China
Zhejiang Greentown Cardiovascular Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial Hospital of Chinese Medicine
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Hospital
🇨🇳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
Wenzhou Central Hospital
🇨🇳Wenzhou, Zhejiang, China
Wenzhou Hospital of Traditional Chinese Medicine
🇨🇳Wenzhou, Zhejiang, China
Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital
🇨🇳Beijing, China
Wenzhou People'S Hospital
🇨🇳Wenzhou, Zhejiang, China
The Fourth Hospital of Changhsa
🇨🇳Changsha, China