NCT01805531已完成不适用
Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 411
- 主要终点
- Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
研究概览
简要总结
National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male subjects ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation
- •Who are treated with Vitamin K antagonists (VKA) with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
- •Who start treatment with rivaroxaban to prevent stroke or non-CNS (central nervous system) systemic embolism
- •With anticoagulation therapy planned for at least 6 months
排除标准
- •Contra indication to the use of Xarelto as described in the Summary of Product Characteristics (SmPC); key contra indications are:
- •Hypersensitivity to the active substance or to any of the excipients listed in SmPC section 6.
- •Lesion or condition at significant risk of major bleeding
- •Concomitant treatment with any other anticoagulant agent
- •Clinically significant active bleeding
- •Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
- •Pregnancy and breast feeding
研究组 & 干预措施
Rivaroxaban
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Change of the Anti Clot Treatment Scale (ACTS) score at 3 months compared with baseline score
时间窗: After 3 months
次要结局
- Continuation rate at 1, 3 and 6 months(After 1, 3 and 6 months)
- Patient's compliance with VKA treatment at baseline and with Xarelto treatment at 1, 3 and 6 months assessed by the investigator as good (≥80%), average (50-80%) or poor (<50%)(After 1, 3 and 6 months)
- Physician's satisfaction at 1, 3 and 6 months assessed by a 5-point Likert scale response ("very satisfied", "satisfied", "neutral", "unsatisfied" or "very unsatisfied")(After 1, 3 and 6 months)
- Change of ACTS score after 1 and 6 months of treatment(After 1 and 6 months)
- Change of SF36 score at 1, 3 and 6 months (health related quality of life determined by SF36 questionnaire)(After 1, 3 and 6 months)
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