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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-valvular Atrial Fibrillation

Intervention / Treatment
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* Drug: Edoxaban


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NVAF patients<br>NVAF adult patients with one or more risk factors treated with edoxaban. | Drug: Edoxaban<br>* This is a non-interventional, observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of mortality (cardiovascular and all-cause) following edoxaban treatment |  | Baseline up to 2 years post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment |  | Baseline up to 2 years post treatment | 
| Duration of exposure to edoxaban treatment in NVAF patients |  | Baseline up to 2 years post treatment | 
| Compliance rate of edoxaban treatment in NVAF patients |  | Baseline up to 2 years post treatment | 
| Proportion of participants who discontinued edoxaban treatment in NVAF patients |  | Baseline up to 2 years post treatment | 
| Number of interventions related to atrial fibrillation/edoxaban in NVAF patients |  | Baseline up to 2 years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-valvular atrial fibrillation, Edoxaban