- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747496
Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China (ETNA-AF-CHINA)
Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China
- Beijing Chao-Yang Hospital Capital Medical University
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Beijing, China
- Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital
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Changsha, China
- The Fourth Hospital of Changhsa
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Changping District
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Beijing, Changping District, China
- Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
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Chaoyang District
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Beijing, Chaoyang District, China
- Aviation General Hospital of China Medical University
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Beijing, Chaoyang District, China
- Beijing Anzhen Hospital, Capital Medical University
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Beijing, Chaoyang District, China
- Beijing Chao-Yang Hospital Capital Medical University
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Dongcheng District
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Beijing, Dongcheng District, China
- Beijing Hospital
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Beijing, Dongcheng District, China
- Beijing Tongren Hospital,Cmu
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Gansu
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Lanzhou, Gansu, China
- The First Hospital of Lanzhou University
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Guangdong
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Guangzhou, Guangdong, China
- The First Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, China
- The First Affiliated Hospital, Sun Yat-sen University
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Guangzhou, Guangdong, China
- the Second Affiliated Hospital of Guangzhou Medical University
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Guangzhou, Guangdong, China
- Guangzhou First People's Hospital
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Guangzhou, Guangdong, China
- Guangzhou Panyu Central Hospital
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Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hospital,Sun Yat-sen University
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Guangzhou, Guangdong, China
- Zhujiang hospital of southern medical university
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Guangzhou, Guangdong, China
- The First Affiliated Hospital of Jinan University
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Guangzhou, Guangdong, China
- Guangdong Second Provincial General Hospital
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Guangxi Province
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Nanjing, Guangxi Province, China
- The First People's Hospital of Nanning
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Nanning, Guangxi Province, China
- The Third People'S Hospital of Nanning
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Heilongjiang
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Harbin, Heilongjiang, China
- Heilongjiang provincial hospital
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Henan
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Kaifeng, Henan, China
- Kaifeng Central Hospital
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Xinxiang, Henan, China
- The Third Affiliated Hospital of Xinxiang Medical University
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Xinxiang, Henan, China
- Xinxiang Central Hospital
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Zhengzhou, Henan, China
- The Second Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, China
- The fifth Affiliated Hospital of Zhengzhou University
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Heping District
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Tianjin, Heping District, China
- Tianjin Medical University General Hospital
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Hexi District
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Tianjin, Hexi District, China
- The Second Hospital of Tianjin Medical University
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Huangpu District
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Shanghai, Huangpu District, China
- Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine
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Hubei
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Langfang, Hubei, China
- Hebei Petro China Center Hospital
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Shiyan, Hubei, China
- Dongfeng General Hospital of Chinese Medicine
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Wuhan, Hubei, China
- The Central Hospital Of Wuhan
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Wuhan, Hubei, China
- Zhongnan Hospital of Wuhan University
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Wuhan, Hubei, China
- Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
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Wuhan, Hubei, China
- Wuhan Third Hospital
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Wuhan, Hubei, China
- Wuhan Puai Hospital
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Wuhan, Hubei, China
- Renmin Hospital of Wuhan University Hubei General Hospital
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Wuhan, Hubei, China
- Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
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Hunan
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Changsha, Hunan, China
- The Third Xiangya Hospital of Central South University
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Changsha, Hunan, China
- Hunan Provincial People's Hospital
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Changsha, Hunan, China
- The First Hospital of Changsha
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Changsha, Hunan, China
- Changsha Central Hospital
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Changsha, Hunan, China
- The Fourth Hospital of Changsha
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Xiangtan, Hunan, China
- Xiangtan Central Hospital
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Jiangsu
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Changzhou, Jiangsu, China
- Changzhou No.2 People's Hospital
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Jiangyin, Jiangsu, China
- Jiangyin People's Hospital
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Kunshan, Jiangsu, China
- The First People'S Hospital of Kunshan
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Nanchang, Jiangsu, China
- Jiangxi Provincial People's Hospital
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Nanjing, Jiangsu, China
- Nanjing Jiangning Hospital
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Nanjing, Jiangsu, China
- The Second Affiliated Hospital of Nanjing Medical University
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Suzhou, Jiangsu, China
- The Second People'S Hospital of Suzhou
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Wuxi, Jiangsu, China
- Affiliated Hospital of Jiangnan University
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Wuxi, Jiangsu, China
- Wuxi People's Hospital
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Xuzhou, Jiangsu, China
- The Affiliated Hospital of Xuzhou Medical University
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Xuzhou, Jiangsu, China
- Xuzhou Central Hospital
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Jilin
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Changchun, Jilin, China
- The Second Hospital of Jilin University
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Changchun, Jilin, China
- Jilin Province People's Hospital
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Changchun, Jilin, China
- The Fourth Hospital of Jilin University
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Liaoning
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Dalian, Liaoning, China
- The First Affiliated Hospital of Dalian Medical University
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Shenyang, Liaoning, China
- The Second Affiliated Hospital of Shenyang Medical College
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Shenyang, Liaoning, China
- China Shenyang Chest Hospital
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Minyun District
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Beijing, Minyun District, China
- Beijing miyun district hospital
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Pudong New Area
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Shanghai, Pudong New Area, China
- Shanghai East Hospital,Tongji University
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Qingpu District
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Shanghai, Qingpu District, China
- Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
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Shandong
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Jinan, Shandong, China
- The Fifth People's Hospital of Jinan
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Weifang, Shandong, China
- Affiliated hospital of Weifang Medical University
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Shangcheng District
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Hangzhou, Shangcheng District, China
- Hangzhou Third Hospital
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Shanxi
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Changzhi, Shanxi, China
- Heping Hospital Affiliated to Changzhi Medical College
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Taiyuan, Shanxi, China
- Shanxi Bethune Hospital
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Taiyuan, Shanxi, China
- Shanxi Provincial People's Hospital
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Taiyuan, Shanxi, China
- Shanxi Cardiovascular Hospital
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Taiyuan, Shanxi, China
- Taiyuan Central Hospital of Shanxi Medical University
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Sichuan
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Chengdu, Sichuan, China
- West China Hospital, Sichuan University
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Tongzhou District
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Beijing, Tongzhou District, China
- Beijing Chest Hospital, Capital Medical University
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Xicheng District
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Beijing, Xicheng District, China
- Peking Union Medical College Hospital
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Beijing, Xicheng District, China
- Peking University First Hospital
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Xinjiang Province
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Ürümqi, Xinjiang Province, China
- The first affiliated hospital of Xinjiang Medical University
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Xuanwu District
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Beijing, Xuanwu District, China
- Xuanwu Hospital Capital Medical University
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Xuhui District
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Shanghai, Xuhui District, China
- Longhua Hospital Shanghai University of Traditional Chinese Medicine
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Yangpu District
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Shanghai, Yangpu District, China
- Shanghai Yangpu East Hospital
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Yunnan
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Kunming, Yunnan, China
- The First Hospital of Kunming
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Yuzhong District
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Chongqing, Yuzhong District, China
- Chongqing General Hospital
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Chongqing, Yuzhong District, China
- The First Affiliated Hospital of Chongqing Medical University
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Chongqing, Yuzhong District, China
- The Second Affiliated Hospital of Chongqing Medical University
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Zhejiang
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Hangzhou, Zhejiang, China
- Zhejiang Provincial People's Hospital
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Hangzhou, Zhejiang, China
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Hangzhou, Zhejiang, China
- Zhejiang Hospital
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Hangzhou, Zhejiang, China
- Zhejiang Provincial Hospital of Chinese Medicine
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Hangzhou, Zhejiang, China
- Zhejiang Greentown Cardiovascular Hospital
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Jiaxing, Zhejiang, China
- The First hospital of Jiaxing
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Jiaxing, Zhejiang, China
- The second Hospital of Jiaxing
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Ningbo, Zhejiang, China
- Ningbo First Hospital
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Wenzhou, Zhejiang, China
- The First Affiliated Hospital of Wenzhou Medical University
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Wenzhou, Zhejiang, China
- Wenzhou Hospital of Traditional Chinese Medicine
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Wenzhou, Zhejiang, China
- Wenzhou Central Hospital
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Wenzhou, Zhejiang, China
- Wenzhou People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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NVAF patients
NVAF adult patients with one or more risk factors treated with edoxaban.
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This is a non-interventional, observational study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Duration of exposure to edoxaban treatment in NVAF patients
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Compliance rate of edoxaban treatment in NVAF patients
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Proportion of participants who discontinued edoxaban treatment in NVAF patients
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Number of interventions related to atrial fibrillation/edoxaban in NVAF patients
Time Frame: Baseline up to 2 years post treatment
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Baseline up to 2 years post treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSCN-ETNA AF-RWS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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