XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,987
- 主要终点
- Number of patients with symptomatic recurrent venous thromboembolic events
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 venous thoromboembolism (VTE).
The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE 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 or male patients, who are at >=18 years
- •Diagnosis of acute DVT and/or PE, objectively confirmed
- •Indication for anticoagulation therapy for at least 12 weeks
- •Willing to participate in this study and 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
Rivaroxaban
Patients who will be treated for an acute venous thromboembolism (VTE) with rivaroxaban.
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Standard of care
Patients who will be treated for an acute venous thromboembolism (VTE) with current standard of care.
干预措施: Recommended VTE pharmacological treatments according to international guidelines (Drug)
结局指标
主要结局
Number of patients with symptomatic recurrent venous thromboembolic events
时间窗: Up to 2 years
All cause mortality
时间窗: Up to 2 years
Number of major bleedings defined as overt bleeding
时间窗: Up to 2 years
Major bleedings defined as overt bleeding are 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
次要结局
- Treatment satisfaction (patient reported outcomes)(Up to 2 years)
- Number of adverse cardiovascular events(Up to 2 years)
- Number of patients with other symptomatic thromboembolic events(Up to 2 years)