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Non-valvular Atrial FibrillationETNA-AF-CHINANCT04747496

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

An observational study of Non-valvular Atrial Fibrillation, run by Daiichi Sankyo at 97 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-valvular Atrial Fibrillation
What is being tested?
Edoxaban
How many people
5,000 participants
Where
97 sitesChina
Study dates
26 Feb 2021to 27 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with NVAF treated with edoxaban will be enrolled in this non-interventional, observational study.

Who may be able to join

  • 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

Who cannot join

  • Not applicable

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

China97 sites

  • Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University

    Beijing, Changping District

  • Aviation General Hospital of China Medical University

    Beijing, Chaoyang District

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Chaoyang District

  • Beijing Chao-Yang Hospital Capital Medical University

    Beijing, Chaoyang District

  • Beijing Hospital

    Beijing, Dongcheng District

  • Beijing Tongren Hospital,Cmu

    Beijing, Dongcheng District

  • Beijing Miyun District Hospital

    Beijing, Minyun District

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Tongzhou District

  • Peking Union Medical College Hospital

    Beijing, Xicheng District

  • Peking University First Hospital

    Beijing, Xicheng District

  • Xuanwu Hospital Capital Medical University

    Beijing, Xuanwu District

  • Beijing Chao-Yang Hospital Capital Medical University

    Beijing

  • Tsinghua University Affiliated Beijing Tsinghua Changgeng Hospital

    Beijing

  • Jilin Province People'S Hospital

    Changchun, Jilin

  • The Fourth Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • Changsha Central Hospital

    Changsha, Hunan

  • Hunan Provincial People'S Hospital

    Changsha, Hunan

  • The First Hospital of Changsha

    Changsha, Hunan

  • The Fourth Hospital of Changsha

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Fourth Hospital of Changhsa

    Changsha

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi

  • Changzhou No.2 People'S Hospital

    Changzhou, Jiangsu

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Chongqing General Hospital

    Chongqing, Yuzhong District

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Yuzhong District

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Yuzhong District

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong

  • Guangzhou First People'S Hospital

    Guangzhou, Guangdong

  • Guangzhou Panyu Central Hospital

    Guangzhou, Guangdong

  • Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Hangzhou Third Hospital

    Hangzhou, Shangcheng District

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Greentown Cardiovascular Hospital

    Hangzhou, Zhejiang

  • Zhejiang Hospital

    Hangzhou, Zhejiang

  • Zhejiang Provincial Hospital of Chinese Medicine

    Hangzhou, Zhejiang

  • Zhejiang Provincial People'S Hospital

    Hangzhou, Zhejiang

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang

  • Jiangyin People'S Hospital

    Jiangyin, Jiangsu

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang

  • The Fifth People'S Hospital of Jinan

    Jinan, Shandong

  • Kaifeng Central Hospital

    Kaifeng, Henan

  • The First Hospital of Kunming

    Kunming, Yunnan

  • The First People'S Hospital of Kunshan

    Kunshan, Jiangsu

  • Hebei Petro China Center Hospital

    Langfang, Hubei

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • Jiangxi Provincial People'S Hospital

    Nanchang, Jiangsu

  • The First People'S Hospital of Nanning

    Nanjing, Guangxi

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • The Third People'S Hospital of Nanning

    Nanning, Guangxi

  • Ningbo First Hospital

    Ningbo, Zhejiang

  • Shanghai Ninth People'S Hospital,Shanghai Jiaotong University School of Medicine

    Shanghai, Huangpu District

  • Shanghai East Hospital,Tongji University

    Shanghai, Pudong New Area

  • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Qingpu District

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, Xuhui District

  • Shanghai Yangpu East Hospital

    Shanghai, Yangpu District

  • China Shenyang Chest Hospital

    Shenyang, Liaoning

  • The Second Affiliated Hospital of Shenyang Medical College

    Shenyang, Liaoning

  • Dongfeng General Hospital of Chinese Medicine

    Shiyan, Hubei

  • The Second People'S Hospital of Suzhou

    Suzhou, Jiangsu

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi

  • Shanxi Provincial People'S Hospital

    Taiyuan, Shanxi

  • Taiyuan Central Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Medical University General Hospital

    Tianjin, Heping District

  • The Second Hospital of Tianjin Medical University

    Tianjin, Hexi District

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Affiliated Hospital of Weifang Medical University

    Weifang, Shandong

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang

  • Wenzhou Hospital of Traditional Chinese Medicine

    Wenzhou, Zhejiang

  • Wenzhou People'S Hospital

    Wenzhou, Zhejiang

  • Renmin Hospital of Wuhan University Hubei General Hospital

    Wuhan, Hubei

  • The Central Hospital of Wuhan

    Wuhan, Hubei

  • Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology

    Wuhan, Hubei

  • Union Hospital Affiliated With Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuhan Puai Hospital

    Wuhan, Hubei

  • Wuhan Third Hospital

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

  • Wuxi People'S Hospital

    Wuxi, Jiangsu

  • Xiangtan Central Hospital

    Xiangtan, Hunan

  • The Third Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Xinxiang Central Hospital

    Xinxiang, Henan

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • The Fifth Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Edoxaban
Keywords
Non-valvular atrial fibrillation, Edoxaban

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdoxabanDrug

    This is a non-interventional, observational study.

Study groups in NCT04747496
Study groupRoleWhat they receive
NVAF patientsNVAF adult patients with one or more risk factors treated with edoxaban.
Receives: Drug: Edoxaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  2. Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  3. Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  4. Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

Secondary outcomes (11)

  1. Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  2. Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  3. Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  4. Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  5. Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  6. Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  7. Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment

    Measured: Baseline up to 2 years post treatment

  8. Duration of exposure to edoxaban treatment in NVAF patients

    Measured: Baseline up to 2 years post treatment

  9. Compliance rate of edoxaban treatment in NVAF patients

    Measured: Baseline up to 2 years post treatment

  10. Proportion of participants who discontinued edoxaban treatment in NVAF patients

    Measured: Baseline up to 2 years post treatment

  11. Number of interventions related to atrial fibrillation/edoxaban in NVAF patients

    Measured: Baseline up to 2 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start26 Feb 2021
  3. Primary completion27 Nov 2024
  4. Study completion27 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04747496
Sponsor's protocol ID
DSCN-ETNA AF-RWS-001
Acronym
ETNA-AF-CHINA
Status last verified
Jan 2025
First submitted
5 Feb 2021
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

An observational study of Non-valvular Atrial Fibrillation, run by Daiichi Sankyo at 97 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment (time frame: Baseline up to 2 years post treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04747496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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