Clinical trial NCT04747496: Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China
Official title: Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation
Edoxaban
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo (China) Holdings Co., Ltd.
First posted: 2021-02-10
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NVAF treated with edoxaban will be enrolled in this non-interventional, observational study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
Secondary outcomes:
measure: Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment
timeFrame: Baseline up to 2 years post treatment
measure: Duration of exposure to edoxaban treatment in NVAF patients
timeFrame: Baseline up to 2 years post treatment
measure: Compliance rate of edoxaban treatment in NVAF patients
timeFrame: Baseline up to 2 years post treatment
measure: Proportion of participants who discontinued edoxaban treatment in NVAF patients
timeFrame: Baseline up to 2 years post treatment
measure: Number of interventions related to atrial fibrillation/edoxaban in NVAF patients
timeFrame: Baseline up to 2 years post treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
state: Changping District
city: Beijing
country: China
facility: Aviation General Hospital of China Medical University
state: Chaoyang District
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Chaoyang District
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital Capital Medical University
state: Chaoyang District
city: Beijing
country: China
facility: Beijing Hospital
state: Dongcheng District
city: Beijing
country: China
facility: Beijing Tongren Hospital,Cmu
state: Dongcheng District
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People'S Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Nanjing
country: China
facility: The First People'S Hospital of Nanning
state: Guangxi Province
city: Nanning
country: China
facility: The Third People'S Hospital of Nanning
state: Guangxi Province
city: Harbin
country: China
facility: Heilongjiang Provincial Hospital
state: Heilongjiang
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Xinxiang
country: China
facility: The Third Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Fifth Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Heping District
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Hexi District
city: Shanghai
country: China
facility: Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine
state: Huangpu District
city: Langfang
country: China
facility: Hebei Petro China Center Hospital
state: Hubei
city: Shiyan
country: China
facility: Dongfeng General Hospital of Chinese Medicine
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University Hubei General Hospital
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Affiliated With Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Puai Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Third Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Changsha Central Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Provincial People'S Hospital
state: Hunan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The Fourth Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People'S Hospital
state: Jiangsu
city: Jiangyin
country: China
facility: Jiangyin People'S Hospital
state: Jiangsu
city: Kunshan
country: China
facility: The First People'S Hospital of Kunshan
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People'S Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The Second People'S Hospital of Suzhou
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People'S Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Changchun
country: China
facility: Jilin Province People'S Hospital
state: Jilin
city: Changchun
country: China
facility: The Fourth Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: China Shenyang Chest Hospital
state: Liaoning
city: Shenyang
country: China
facility: The Second Affiliated Hospital of Shenyang Medical College
state: Liaoning
city: Beijing
country: China
facility: Beijing Miyun District Hospital
state: Minyun District
city: Shanghai
country: China
facility: Shanghai East Hospital,Tongji University
state: Pudong New Area
city: Shanghai
country: China
facility: Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
state: Qingpu District
city: Jinan
country: China
facility: The Fifth People'S Hospital of Jinan
state: Shandong
city: Weifang
country: China
facility: Affiliated Hospital of Weifang Medical University
state: Shandong
city: Hangzhou
country: China
facility: Hangzhou Third Hospital
state: Shangcheng District
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Provincial People'S Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Central Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
state: Tongzhou District
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Xicheng District
city: Beijing
country: China
facility: Peking University First Hospital
state: Xicheng District
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang Province
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Xuanwu District
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Xuhui District
city: Shanghai
country: China
facility: Shanghai Yangpu East Hospital
state: Yangpu District
city: Kunming
country: China
facility: The First Hospital of Kunming
state: Yunnan
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Yuzhong District
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Yuzhong District
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Yuzhong District
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Greentown Cardiovascular Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of Chinese Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People'S Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Jiaxing
country: China
facility: The Second Hospital of Jiaxing
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Hospital of Traditional Chinese Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou People'S Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital Capital Medical University
city: Beijing
country: China
facility: Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital
city: Changsha
country: China
facility: The Fourth Hospital of Changhsa
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: