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

Completed
Conditions
Non-valvular Atrial Fibrillation
Interventions
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
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
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Exclusion Criteria
  • Not applicable
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
NVAF patientsEdoxabanNVAF adult patients with one or more risk factors treated with edoxaban.
Primary Outcome Measures
NameTimeMethod
Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatmentBaseline up to 2 years post treatment
Secondary Outcome Measures
NameTimeMethod
Proportion of participants who discontinued edoxaban treatment in NVAF patientsBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatmentBaseline up to 2 years post treatment
Duration of exposure to edoxaban treatment in NVAF patientsBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatmentBaseline up to 2 years post treatment
Number of interventions related to atrial fibrillation/edoxaban in NVAF patientsBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatmentBaseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatmentBaseline up to 2 years post treatment
Compliance rate of edoxaban treatment in NVAF patientsBaseline 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

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