Non-valvular Atrial Fibrillation (NVAF)
Conditions
Keywords
Xarelto, SPAF, QOL
Brief summary
The objective of this study is to understand if Rivaroxaban can improve treatment satisfaction of Warfarin patients and assess the safety and effectiveness of Xarelto in real clinical practice. A total of 725 patients are to be enrolled and followed for a 6 months.period. QOL survey will be conducted at month 0, 3, 6 using ACTS/TSQM. This study is categorized as a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
Interventions
DRUGRivaroxaban (Xarelto_ BAY59-7939)
Patients treated with Xarelto under practical manner for SPAF.
Sponsors
Janssen Scientific Affairs, LLC
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients treated by Warfarin for their atrial fibrillation for at least two months at the time of the study initiation. * Rivaroxaban naïve patients * Patients 20 years old or older. * Patients who agree to sign the inform consent
Exclusion criteria
* Patients who are contraindicated by product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires) | Up to 6 months |
| Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin) | Up to 6 months |
| Incidence of events of stroke | Up to 6 months |
| Incidence of events of non-central nervous system embolism | Up to 6 months |
Other
| Measure | Time frame |
|---|---|
| Treatment satisfaction scores at Month 3 and Month 6 by demographic and clinical characteristics | At Month 3 and Month 6 |
Countries
Japan
Outcome results
None listed