Real-world Dosing Patterns of Rivaroxaban in the United States

Study Overview
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Brief Summary
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The primary objective is to assess the proportion of Non-valvular atrial fibrillation (NVAF) patients receiving the standard dose of 20 mg of rivaroxaban or the reduced dose of 15 mg of rivaroxaban. The secondary objective is to determine if dosing patterns for rivaroxaban may be influenced by baseline chronic kidney disease (CKD) status (as a proxy for measured baseline renal function).

Official Title
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Real-world Dosing Patterns of Rivaroxaban in the United States (RIVA-D)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NVAF (non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with International Classification of Disease ICD-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period Evidence of continuous enrollment in MarketScan during 180 days before the date of the first prescription of rivaroxaban Exclusion Criteria: Patients <18 years of age Patients with valvular AF (atrial fibrillation) Pregnancy Malignant cancers Transient cause of AF Patients with VTE (Venous thromboembolism), pulmonary embolism or DVT (Deep Vein Thrombosis) Patients with major surgery defined as hip or knee replacement Prescriptions of OACs (Oral anticoagulants) (apixaban,warfarin, dabigatran, rivaroxaban) before index date Prescription of more than one OAC on the index date

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 |
| --- | --- |
| NVAF patients receiving 20 mg rivaroxaban<br>NVAF patients who receive a standard dose of rivaroxaban (20 mg daily) | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* As prescribed by treating physicians<br>|
| NVAF patients receiving 15 mg rivaroxaban<br>NVAF patients who receive a reduced dose of rivaroxaban (15 mg daily) | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* As prescribed by treating physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of NVAF patients receiving 20 mg Rivaroxaban |  | At baseline | 
| Number of NVAF patients receiving 15 mg Rivaroxaban |  | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline renal function |  | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-valvular atrial fibrillation (NVAF), Prevention, Stroke