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Completed

NCT Number: NCT04747496

Real-world Study on Edoxaban Treatment 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.

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Key information

Conditions

Non-valvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University, Beijing, Changping District, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edoxaban

Drug

This is a non-interventional, observational study.

Primary outcomes

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

Secondary outcomes

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

  8. Duration of exposure to edoxaban treatment in NVAF patients

    Time frame: Baseline up to 2 years post treatment

  9. Compliance rate of edoxaban treatment in NVAF patients

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

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

    Time frame: Baseline up to 2 years post treatment

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Daiichi Sankyo Co., Ltd.

Registry information

Official study title

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

Acronym: ETNA-AF-CHINA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2021
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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