Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 5,145
- 主要终点
- All cause mortality
研究概览
简要总结
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.
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 patients
- •Patients >= 18 years
- •Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up
排除标准
- •Exclusion criteria must be read in conjunction with the local product information.
研究组 & 干预措施
Group 1
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Group 2
干预措施: Standard of care (Drug)
结局指标
主要结局
All cause mortality
时间窗: after approximately 2 years or 30 days after stop of therapy
Number of patients with symptomatic recurrent venous thromboembolic events
时间窗: after approximately 2 years or 30 days after stop of therapy
Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site
时间窗: after approximately 2 years or 30 days after stop of therapy
次要结局
- Treatment satisfaction (patient reported outcomes)(after approximately 2 years or 30 days after stop of therapy)
- Safety variables will be summarized using descriptive statistics based on adverse cardiac events collection(after approximately 2 years or 30 days after stop of therapy)
- Number of patients with other symptomatic thromboembolic events(after approximately 2 years or 30 days after stop of therapy)