Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 741
- 主要终点
- Incidence of events of stroke
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who are contraindicated by product label
研究组 & 干预措施
Group 1
Patients treated with Xarelto under practical manner for SPAF.
干预措施: Rivaroxaban (Xarelto_ BAY59-7939) (Drug)
结局指标
主要结局
Incidence of events of stroke
时间窗: Up to 6 months
Incidence of events of non-central nervous system embolism
时间窗: Up to 6 months
Improvement of treatment satisfaction (Evaluated through ACTS and TSQM questionnaires)
时间窗: 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)
时间窗: Up to 6 months
次要结局
未报告次要终点