Effectiveness and Safety of Rivaroxaban Used in Clinical Practice of Extended Anticoagulation for Pulmonary Embolism Patients in China, XAPEC-EXT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 496
- 主要终点
- Net clinical benefit
研究概览
简要总结
Domestic and international guidelines for the management of pulmonary embolism have suggested that the standard duration of anticoagulation should cover at least 3 months.Whether extended anticogulation therapy shoud balance the efficacy and safety of the therapy.Nevertheless, the concerning about bleeding may affect the decision on the extended anticoagulation for pulmonary embolism patients who may benefit from continuing anticoagulation. Rivaroxaban is an oral direct factor Xa inhibitor, it does not require routine laboratory monitoring and has no food interactions and only a few drug interactions compared to standard of care with the recommendation for the treatment of pulmonary embolism by several guidelines.Our study aims to acquire the data of effectiveness and safety of rivaroxaban used in clinical practice of extended anticoagulation for pulmonary embolism patients in China through this perspective observational study.
详细描述
This is a perspective, multicenter, single-arm, non-interventional, and observational study. The primary objective is to evaluate the effectiveness and safety of rivaroxaban used in extended treatment of pulmonary embolism in a real-world.The secondary objective aims to analyze the drug usage pattern of rivaroxaban, patient satisfaction and medical resource utilization used in extended treatment of pulmonary embolism in a real-world.496 subjects will be enrolled in this study. The primary outcome of this study is net clinical benefit.
All patients with rivaroxaban should be followed up to 12 months, or about 30 days after the end of rivaroxaban treatment if discontinued before the completion of 12 months. Follow up visits occur at initial visit, 3, 6, 9, 12 months after the initial visit, where such data have been collected as part of routine clinical practice, by phone and or face to face interview.
During each follow up visit, the date of visit, physical examination, ACTS and, as applicable, changes in the concomitant medication, changes in concomitant disease,changes in pulmonary embolism and/or treatment regimen, new diagnosis of venous thromboembolism, medical resources utilization, and adverse events will be obtained and recorded.
Starting with the first application of rivaroxaban after enrollment into the study or follow-up period, all AEs would be documented. For each AE, the investigator must assess and document the seriousness, duration, relationship to product, action taken and outcome of the event.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female adults aged 18 years or above
- •Objectively confirmed diagnosis of symptomatic or asymptomatic pulmonary embolism
- •Already received 6 to 12 months anticoagulant
- •Indication for extend anticoagulant for at least 3 months with rivaroxaban( as assessed by the investigator)5)Written informed consent
排除标准
- •Patients with another indication for anticoagulation other than venous thromboembolism.
- •Patients with contraindications listed in rivaroxaban label in china.
- •Patients who participated in another study within 30 days
- •Life expectation less than 3 months
结局指标
主要结局
Net clinical benefit
时间窗: 12 months
Net clinical benefit(the composite of major bleeding and symptomatic recurrent venous thromboembolism)
次要结局
- Adverse events(12 months)
- Clinical related non-major bleeding events(12 months)
- Mortality(12 months)
- The satisfaction with anticoagulant treatment(12 months)
- Length of stay in hospital(12 months)
- The number of outpatient visits(12 months)
- Medical costs due to bleeding or embolism(12 months)
- Drug use patterns(12 months)
- The symptomatic recurrent venous thromboembolism(12 months)
- Major bleeding(12 months)
研究者
Zhenguo Zhai,MD,PhD
Deputy Director of the Second Department of Respiratory and Critical Care Medicine
China-Japan Friendship Hospital