Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latinamerica and EMEA Region

Study Overview
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Brief Summary
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This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.

Official Title
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XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): 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 systemic embolism, and who consent to participate in the study. Exclusion Criteria:

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 descriptivestatistics 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 |  | 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 |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Reasons for switch of rivaroxaban treatment |  | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | 
| Reasons for interruption of rivaroxaban treatment |  | 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 therapy | 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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Atrial Fibrillation, Observation, Stroke, Embolism