Xarelto [SPAF-QOL] Post-marketing Surveillance in Japan
Completed
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)
- Interventions
- Registration Number
- NCT01598051
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 741
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
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Exclusion Criteria
- Patients who are contraindicated by product label
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Rivaroxaban (Xarelto_ BAY59-7939) Patients treated with Xarelto under practical manner for SPAF.
- Primary Outcome Measures
Name Time Method Incidence of events of stroke Up to 6 months Incidence of events of non-central nervous system embolism Up to 6 months 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
- Secondary Outcome Measures
Name Time Method