Atrial Fibrillation
Conditions
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.
Interventions
DRUGRivaroxaban (Xarelto, BAY59-7939)
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
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
South Korea, Taiwan
Outcome results
None listed