Special Drug Use Investigation of Xarelto [SPAF]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 11,310
- 主要终点
- Incidence of ADRs and serious AEs (especially for hemorrhagic events, and liver disfunction with increase of liver-function-relating enzymes including bilirubin)
研究概览
简要总结
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Xarelto for SPAF.
The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice.
A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-valvular atrial fibrillation (NVAF) for whom the decision to be treated with Xarelto was made
- •Patients without experience of using Xarelto prior to the study
排除标准
- •Patients who are contraindicated based on the product label
研究组 & 干预措施
Group 1
Patients treated with Xarelto for the purpose of prevention of ischemic stroke and systemic embolism
干预措施: Rivaroxaban(Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
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 2 years
Incidence of events of stroke
时间窗: Up to 5 years
Incidence of events of non-central nervous system embolism
时间窗: Up to 5 years
次要结局
- Determination of patient's demography to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey(Baseline)
- Determination of patient's medical history to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey(Baseline)
- Determination of patient's background to affect the safety and efficacy of Xarelto using standard observational survey and follow-up survey(Baseline)