Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 113
- 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 in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) 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 or male subject ≥ 18 years of age,
- •With a diagnosis of acute DVT treated with VKA with issues for at least the 4 previous weeks (issues are assessed on medical judgment)
- •Who intends to start rivaroxaban for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT
- •With anticoagulation therapy planned for at least 3 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
20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment
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
- 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)
- 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)
- Continuation rate at 1, 3 and 6 months(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)