Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Daiichi Sankyo
- Enrollment
- 5,000
- Locations
- 96
- Primary Endpoint
- Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
NVAF patients
NVAF adult patients with one or more risk factors treated with edoxaban.
Intervention: Edoxaban (Drug)
Outcomes
Primary Outcomes
Incidence (including 95% confidence intervals) of clinically related non-major bleeding events following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of adverse events/adverse drug reactions following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of major bleeding events following edoxaban treatment
Time Frame: Baseline up to 2 years post treatment
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
- Proportion of participants who discontinued edoxaban treatment in NVAF patients(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)
- Duration of exposure to edoxaban treatment in NVAF patients(Baseline up to 2 years post treatment)
- 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 venous thromboembolism (VTE) following edoxaban treatment(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)
- 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 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)
- Compliance rate of edoxaban treatment in NVAF patients(Baseline up to 2 years post treatment)