Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Study Overview
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Brief Summary
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The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.

Official Title
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Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Warfarin
* Drug: Apixaban
* Drug: Dabigatran
* Drug: Rivaroxaban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old as of the index date At least 1 diagnosis of atrial fibrillation in the 12 months prior to or on index date, identified by any medical claim At least one year of baseline period and continuous enrollment for at least 12 months prior to index date Individuals with NVAF who were using oral anticoagulants (i.e., warfarin, dabigatran, rivaroxaban and apixaban) within the study period beginning Jan 1, 2012 through December 31, 2013 or last date of the last data cut available at the time of execution of the study Exclusion Criteria: Patients with evidence of valvular heart disease, thyrotoxicosis, pericarditis, mitral stenosis, Venous thromboembolism(VTE), heart surgery, and endocarditis during the baseline period any time prior to or on index date Patients with any evidence of pregnancy at any time during the baseline will be excluded

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 |
| --- | --- |
| Patients using Warfarin<br>Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin | Drug: Warfarin<br> <br> |
| Patients using Apixaban<br>Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban | Drug: Apixaban<br> <br> |
| Patients using Dabigatran<br>Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran | Drug: Dabigatran<br> <br> |
| Patients using Rivaroxaban<br>Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban | Drug: Rivaroxaban<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Major Bleeding event |  | Up to 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Any Bleeding event |  | Up to 25 months | 
| Major Bleeding-Related Healthcare Utilization | (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event ) | Up to 25 months | 
| Any Bleeding-Related Healthcare Utilization | (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event ) | Up to 25 months | 
| Major Bleeding-Related direct medical cost | (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event) | Up to 25 months | 
| Any Bleeding-Related direct medical cost | (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event) | Up to 25 months |