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.
Study Type
OBSERVATIONAL
Enrollment
504
15 mg and 20 mg (OD)
Sunshine Hospital
Secunderabad, National Capital Territory of Delhi, India
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.
Time frame: Up to 18 months
Incidence of treatment-emergent AEs
Time frame: Up to 18 months
Incidence of treatment-emergent SAEs
Time frame: 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).
Time frame: Up to 18 months
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
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Up to 18 months
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