A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

Study Overview
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Brief Summary
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The purpose of this observational study is to understand real-world oral anticoagulants (OAC) (warfarin, apixaban, dabigatran, edoxaban and rivaroxaban) usage for non-valvular atrial fibrillation (NVAF) patients.

Official Title
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Retrospective Medical Chart Review Study for Non-valvular Atrial Fibrillation Patients Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

Conditions
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Non-Valvular Atrial Fibrillation (NVAF)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020. Exclusion Criteria: Had no data of serum creatinine in the participant's medical records Had no data of body weight in the participant's medical records Were given oral anticoagulant (OAC) for treatment of diseases other than atrial fibrillation (AF) Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| Cohort 1<br>Non-valvular atrial fibrillation (NVAF) participants receiving oral anticoagulant - Warfarin | |
| Cohort 2<br>NVAF participants receiving oral anticoagulant - Apixaban | |
| Cohort 3<br>NVAF participants receiving oral anticoagulant - Dabigatran | |
| Cohort 4<br>NVAF participants receiving oral anticoagulant - Edoxaban | |
| Cohort 5<br>NVAF participants receiving oral anticoagulant - Rivaroxaban | |
| Cohort 6<br>NVAF participants not receiving oral anticoagulants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specialization of the treating physician |  | At Baseline | 
| Distribution of socio-demographic characteristics of NVAF participants: Age group |  | At Baseline | 
| Distribution of socio-demographic characteristics of NVAF participants: Gender |  | At Baseline | 
| Distribution of socio-demographic characteristics of NVAF participants: Body weight |  | At Baseline | 
| Distribution of socio-demographic characteristics of NVAF participants: Height |  | At Baseline | 
| Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI) |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Drinking information |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Smoking information |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Internal medical device information |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Degree of life freedom |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Hospitalization/outpatient status |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure |  | At Baseline | 
| Distribution of outcomes of NVAF participants: Pulse rate |  | At Baseline | 
| Distribution of clinical characteristics of NVAF participants: Risk factors for stroke |  | At Baseline | 
| Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding |  | At Baseline | 
| Distribution of clinical characteristics of NVAF participants: Comorbidities |  | At Baseline | 
| Distribution of outcomes of NVAF participants: OAC prescription and administration status |  | At Baseline | 
| Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE) |  | At Baseline | 
| Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB) |  | At Baseline | 
| Distribution of medication prescribed during baseline: calcium antagonist |  | At Baseline | 
| Distribution of medication prescribed during baseline: Antiarrhythmic drug |  | At Baseline | 
| Distribution of medication prescribed during baseline: Statin |  | At Baseline | 
| Distribution of medication prescribed during baseline: proton pump inhibitor (PPI) |  | At Baseline | 
| Distribution of medication prescribed during baseline: H2-receptor antagonist |  | At Baseline | 
| Distribution of medication prescribed during baseline: aspirin |  | At Baseline | 
| Distribution of medication prescribed during baseline: P2Y12 inhibitor |  | At Baseline | 
| Distribution of medication prescribed during baseline: Other antiplatelet drugs |  | At Baseline | 
| Distribution of medication prescribed during baseline: Other anticoagulants |  | At Baseline | 
| Distribution of medication prescribed during baseline: P-glycoprotein inhibitor |  | At Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japan, BMS-562247, Apixaban, Atrial fibrillation, Oral Anticoagulants, Retrospective Study