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

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment-naïve NVAF patients in Korea and Taiwan	Rivaroxaban (Xarelto, BAY59-7939)	Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation

Primary Outcome Measures

Name	Time	Method
Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)	Up to one year	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.

Secondary Outcome Measures

Name	Time	Method
SAEs	Up to one year	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
All-cause mortality	Up to one year	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
AEs	Up to one year	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Non-major bleeding events	Up to one year	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Symptomatic thromboembolic events	Up to one year	All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy	Up to one year	Start date and stop date will be collected to receive information on drug persistence

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