Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function

Study Overview
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Brief Summary
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In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.

Official Title
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Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population.

Conditions
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Non-valvular Atrial Fibrillation (NVAF)

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 ≥ 20 years of age Diagnosis of non-valvular atrial fibrillation (NVAF) Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value) Exclusion Criteria: Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics Patients participating in an investigational program with interventions outside of routine clinical practice. Planned treatment with other anticoagulants Expected renal-replacement therapy within the next 3 months

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 |
| --- | --- |
| Rivaroxaban<br>Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE). | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* The adminstration dose is decided by the attending physician in advance based on the patients' CrCl and in compliance with local market authorization of rivaroxaban.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding events |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs) and serious adverse events (SAEs) |  | Up to 12 months | 
| Occurrence of All-cause mortality |  | Up to 12 months | 
| Occurrence of non-major bleeding events |  | Up to 12 months | 
| Occurrence of symptomatic thromboembolic events |  | Up to 12 months | 
| Day(s) of rivaroxaban treatment: start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy (in case of treatment discontinuation, switch, or interruption, the reason will be recorded) |  | Up to 12 months | 
| Changes in creatinine clearance (CrCl) from baseline |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke