A Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)

Study Overview
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Brief Summary
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This study is planned to collect prospective data and evaluate the safety and effectiveness of rivaroxaban for the prevention of stroke and systemic embolism in Indian patients with NVAF when used in clinical practice under real-life conditions. The study will be conducted in routine clinical practice settings. Approximately 1000 patients from India will be enrolled in this study. Patients will be observed for maximum period of 12 months after the start of Xarelto treatment or until it is no longer possible (e.g. lost to follow-up, death, withdrawal) before the end of the observation period. The decision by the investigator to start with of Xarelto must be independent of the inclusion of a patient to the study.

Official Title
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A Real-World, Prospective, Observational Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto®) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF)

Conditions
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Non-valvular Atrial Fibrillation (NVAF)

Intervention / Treatment
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* Drug: Rivaroxaban (Xarelto,Bay 59-7939)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient should be an adult female or male, ≥18 years of age; Patient should be diagnosed with NVAF and initiated with rivaroxaban treatment for prevention of stroke or systemic embolism per investigator's routine treatment practice; Patient should not have received rivaroxaban in the past; Patient/patient's legally acceptable representative should be willing to provide written informed consent. Exclusion Criteria: Patient has contraindications to receive rivaroxaban therapy according to local prescribing information; Patient is receiving anticoagulant therapy for indication other than NVAF and that needs to be continued as per discretion of treating physician; Patient is participating in an investigational program with interventions outside of routine clinical practice.

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 |
| --- | --- |
| Treatment<br>Rivaroxaban treatment-naïve patients, at least 18 years of age and presenting with NVAF will be considered eligible for participation in this study only after the decision to treat with rivaroxaban has been made by the treating physician. | Drug: Rivaroxaban (Xarelto,Bay 59-7939)<br>* 15 mg and 20 mg (OD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major bleeding events | Major bleeding events include: Fatal bleeding Symptomatic bleeding in a critical area or organ Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. Hemoglobin level; or Need for transfusion of packed red blood cells or whole blood. | Up to 18 months | 
| Incidence of treatment-emergent AEs |  | Up to 18 months | 
| Incidence of treatment-emergent SAEs |  | Up to 18 months | 
| Incidence of all-cause death | Deaths will be adjudicated as either vascular (e.g., due to stroke, embolism, myocardial infarction, or arrhythmia) or non-vascular (e.g., malignancy or infection). | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic thromboembolic events | The date of thromboembolic events, manner in which thromboembolic events were managed in the routine practice setting, and their outcomes will be recorded. The thromboembolic events include: Stroke and transient ischemic attack (TIA) Systemic embolism Myocardial infarction | Up to 18 months | 
| Non-major bleeding events | The date of non-major bleeding events, treatment approaches employed during non-major bleeding events, and the associated outcomes will be collected. | Up to 18 months | 
| AE rates in the different NVAF risk factor categories | Rates of AEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke(CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED). | Up to 18 months | 
| SAE rates in the different NVAF risk factor categories | Rates of SAEs across patients with different baseline risk profiles for stroke or bleeding calculated using Congestive heart failure, Hypertension, Age, Diabetes mellitus, Stroke (CHADS2), Vascular disease, Age, Sex category (CHA2DS2-VASc), or Hypertension, Abnormal liver/renal function, Stroke history, Bleeding predisposition, Labile international normalized ratios, Elderly, Drug/alcohol usage (HAS-BLED). | Up to 18 months | 
| Treatment persistence with rivaroxaban | Treatment persistence with rivaroxaban therapy will be defined as the absence of a gap of >60 days between two doses of rivaroxaban, without any switch to alternative anticoagulant. Reasons for any switch from or interruption of rivaroxaban therapy during the observation period will be collected and summarized. | Up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke;, Systemic embolism