Trial Condition(s):
Non-valvular Atrial fibrillation (NVAF)
Xarelto [SPAF-QOL] post-marketing surveillance in Japan
Bayer Identifier:
16296
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Japan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Treatment satisfaction under Rivaroxaban (ACTS/TSQM)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)Timeframe: 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)Timeframe: Up to 6 months
- Incidence of events of strokeTimeframe: Up to 6 months
- Incidence of events of non-central nervous system embolismTimeframe: Up to 6 months
Additional Information
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