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.
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 Type
OBSERVATIONAL
Enrollment
5,000
This is a non-interventional, observational study.
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 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 mortality (cardiovascular and all-cause) following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of stroke (ischemic and hemorrhagic) following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of systemic embolic event (SEE) following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of transient ischemic attack (TIA) following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of major adverse cardiovascular events (MACE) following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of venous thromboembolism (VTE) following edoxaban treatment
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Beijing Tsinghua Changgung Hospital Affiliated Hospital of Tsinghua University
Beijing, Changping District, China
Aviation General Hospital of China Medical University
Beijing, Chaoyang District, China
Beijing Anzhen Hospital, Capital Medical University
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Beijing Chao-Yang Hospital Capital Medical University
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Beijing Hospital
Beijing, Dongcheng District, China
Beijing Tongren Hospital,Cmu
Beijing, Dongcheng District, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
Guangzhou First People'S Hospital
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
...and 87 more locations
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of acute coronary syndrome (ACS) following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Incidence (including 95% confidence intervals) of hospitalizations related to cardiovascular condition following edoxaban treatment
Time frame: Baseline up to 2 years post treatment
Duration of exposure to edoxaban treatment in NVAF patients
Time frame: Baseline up to 2 years post treatment
Compliance rate of edoxaban treatment in NVAF patients
Time frame: Baseline up to 2 years post treatment
Proportion of participants who discontinued edoxaban treatment in NVAF patients
Time frame: Baseline up to 2 years post treatment
Number of interventions related to atrial fibrillation/edoxaban in NVAF patients
Time frame: Baseline up to 2 years post treatment