Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Major bleedings
研究概览
简要总结
EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited. Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China.
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 symptomatic or asymptomatic PE, objectively confirmed
- •Indication for anticoagulation therapy for at least 3 months (as assessed by the attending investigator)
- •Willing to participate in this study, having given informed consent and willing to participate in the routine follow-up during the period of rivaroxaban treatment.
排除标准
- •Pre-treatment with any anticoagulant for the index PE more than the 2 weeks.
- •Patients with another indication for anticoagulation other than VTE.
- •Patients who participated in another study within 30 days
研究组 & 干预措施
Rivaroxaban
Anticoagulation with rivaroxaban
干预措施: Rivaroxaban(Xarelto, BAY 59-7939) (Drug)
结局指标
主要结局
Major bleedings
时间窗: Up to 12 months
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: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal; or death.
次要结局
- Symptomatic recurrent venous thromboembolic events(Up to 12 months)
- Major adverse cardiac events(Up to 12 months)
- Other symptomatic thromboembolic events(Up to 12 months)
- Drug utilization(Up to 12 months)
- Number of participants with adverse events and serious adverse events(Up to 12 months)
- Patient treatment satisfaction by using questionnaire of ACTS (Anti-Clot Treatment Scale)(Up to 12 months)