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NCT04747496 Clinical Trial

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

Non-valvular Atrial Fibrillation Clinical Trial

— ETNA-AF-CHINA  

Official title:
Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04747496
Other study ID # DSCN-ETNA AF-RWS-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 26, 2021
Est. completion date October 27, 2024

Study information
Verified date September 2023
Source Daiichi Sankyo, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Active, not recruiting
Enrollment 5000
Est. completion date October 27, 2024
Est. primary completion date October 27, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Edoxaban
This is a non-interventional, observational study.

Locations
Country Name City State
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 Chao-Yang Hospital Capital Medical University Beijing
China Beijing Chest Hospital, Capital Medical University Beijing Tongzhou District
China Beijing Hospital Beijing Dongcheng District
China Beijing Miyun District Hospital Beijing Minyun District
China Beijing Tongren Hospital,Cmu Beijing Dongcheng District
China Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University Beijing Changping District
China Peking Union Medical College Hospital Beijing Xicheng District
China Peking University First Hospital Beijing Xicheng District
China Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital Beijing
China Xuanwu Hospital Capital Medical University Beijing Xuanwu District
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 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 Changhsa Changsha
China The Fourth Hospital of Changsha Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Heping Hospital Affiliated to Changzhi Medical College Changzhi Shanxi
China Changzhou No.2 People'S Hospital Changzhou Jiangsu
China West China Hospital, Sichuan University Chengdu Sichuan
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 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning
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 Hangzhou Third Hospital Hangzhou Shangcheng 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 Heilongjiang Provincial Hospital Harbin Heilongjiang
China Jiangyin People'S Hospital Jiangyin Jiangsu
China The First Hospital of Jiaxing Jiaxing Zhejiang
China The Second Hospital of Jiaxing Jiaxing Zhejiang
China The Fifth People'S Hospital of Jinan Jinan Shandong
China Kaifeng Central Hospital Kaifeng Henan
China The First Hospital of Kunming Kunming Yunnan
China The First People'S Hospital of Kunshan Kunshan Jiangsu
China Hebei Petro China Center Hospital Langfang Hubei
China The First Hospital of Lanzhou University Lanzhou Gansu
China Jiangxi Provincial People'S Hospital Nanchang Jiangsu
China Nanjing Jiangning Hospital Nanjing Jiangsu
China The First People'S Hospital of Nanning Nanjing Guangxi Province
China The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
China The Third People'S Hospital of Nanning Nanning Guangxi Province
China Ningbo First Hospital Ningbo Zhejiang
China Longhua Hospital Shanghai University of Traditional Chinese Medicine Shanghai Xuhui District
China Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University Shanghai Qingpu District
China Shanghai East Hospital,Tongji University Shanghai Pudong New Area
China Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine Shanghai Huangpu District
China Shanghai Yangpu East Hospital Shanghai Yangpu District
China China Shenyang Chest Hospital Shenyang Liaoning
China The Second Affiliated Hospital of Shenyang Medical College Shenyang Liaoning
China Dongfeng General Hospital of Chinese Medicine Shiyan Hubei
China The Second People'S Hospital of Suzhou Suzhou Jiangsu
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 The Second Hospital of Tianjin Medical University Tianjin Hexi District
China Tianjin Medical University General Hospital Tianjin Heping District
China The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Province
China Affiliated Hospital of Weifang Medical University Weifang Shandong
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 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 Affiliated Hospital of Jiangnan University Wuxi Jiangsu
China Wuxi People'S Hospital Wuxi Jiangsu
China Xiangtan Central Hospital Xiangtan Hunan
China The Third Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
China Xinxiang Central Hospital Xinxiang Henan
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
China Xuzhou Central Hospital Xuzhou Jiangsu
China The Fifth Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (2)
Lead Sponsor Collaborator
Daiichi Sankyo, Inc. Daiichi Sankyo (China) Holdings Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment Baseline up to 2 years post treatment
Primary Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment Baseline up to 2 years post treatment
Primary Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment Baseline up to 2 years post treatment
Primary Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment Baseline up to 2 years post treatment
Secondary Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment Baseline up to 2 years post treatment
Secondary Duration of exposure to edoxaban treatment in NVAF patients Baseline up to 2 years post treatment
Secondary Compliance rate of edoxaban treatment in NVAF patients Baseline up to 2 years post treatment
Secondary Proportion of participants who discontinued edoxaban treatment in NVAF patients Baseline up to 2 years post treatment
Secondary Number of interventions related to atrial fibrillation/edoxaban in NVAF patients Baseline up to 2 years post treatment
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Completed NCT04722679 - A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.
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