Evaluation of Safety and Effectiveness on Oral Anticoagulants

Study Overview
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Brief Summary
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This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment

Official Title
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Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals greater than or equal to 20 years old as of the index date At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date Exclusion Criteria: Patient's medical records indicating pregnancy during the follow-up period Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date Had > 1 OAC prescription in the patient's medical records on the index date Other protocol defined inclusion/exclusion criteria could 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 |
| --- | --- |
| Patient initiating warfarin<br> | Other: Non-Interventional<br>* Non-Interventional<br>|
| Patient initiating apixaban<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major bleeding among oral anticoagulant (OAC) initiators |  | Maximum 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thromboembolic events |  | Maximum 3 years | 
| Incidence of stoke/SE (secondary event) among OAC initiators |  | Maximum 3 years | 
| Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr | CCr creatinine clearance (< 50ml/min and > 50ml/min) | Maximum 3 years | 
| Incidence of cardiovascular/all cause death among OAC initiators |  | Maximum 3 years | 
| Incidence of myocardial infarction among OAC initiators |  | Maximum 3 years | 
| Incidence of major adverse cardiac event among OAC initiators |  | Maximum 3 years | 
| Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate) | CCr (< 50ml/min and > 50ml/min) | Maximum 3 years | 
| Incidence of myocardial infarction among OAC initiators stratified by CCr | CCr (< 50ml/min and > 50ml/min) | Maximum 3 years | 
| Incidence of major adverse cardiac event among OAC initiators stratified by CCr | CCr (< 50ml/min and > 50ml/min) | Maximum 3 years | 
| Distribution of clinical characteristics among OAC initiators | Clinical characteristics will be summarized using descriptive statistics | Maximum 3 years |