Xarelto on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Treatment-naïve Asian Patients With Non-valvular Atrial Fibrillation

Bayer1,216 enrolled

Overview

The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.

The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Study Type

OBSERVATIONAL

Enrollment

1,216

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban (Xarelto, BAY59-7939)DRUG

Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female and male patients aged 19 years or older (Korea) and aged 20 years or older (Taiwan) * Diagnosis of NVAF * Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice * Treatment naïve regarding stroke prevention for atrial fibrillation * Signed informed consent Exclusion Criteria: * Contraindications for rivaroxaban according to the local market authorization/summary of product characteristics (SmPC) * Patients participating in an investigational program with interventions outside of routine clinical practice

Locations (2)

Different facilities

Multiple Locations, South Korea

Different facilities

Multiple Locations, Taiwan

Outcomes

Primary Outcomes

Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)

Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with: * A fall in hemoglobin of ≥2 g/dL, or * A transfusion of ≥2 units of packed red blood cells or whole blood, or * Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or * Death.

Time frame: Up to one year