Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia

Study Overview
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Brief Summary
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This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.

Official Title
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Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study

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: Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.

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 |
| --- | --- |
| Group 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated major bleeding events |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| All cause mortality |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjudicated symptomatic thromboembolic events |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Healthcare resource | Number of healthcare professional visits and hospitalizations due to anticoagulation | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Adverse events rates in the different AF risk factor categories |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Embolism, Atrial Fibrillation