NCT01029743已完成不适用
Xarelto® Regulatory Post-Marketing Surveillance
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,388
- 主要终点
- Adverse event collection
研究概览
简要总结
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).
- Known and unknown adverse reactions, especially serious adverse reactions
- Incidence of adverse reactions under the routine drug use
- Factors that may affect the safety of the drug
- Factors that may affect the effectiveness of the drug
- Other safety information related to overuse, drug interaction and laboratory abnormalities
- Other adverse reactions
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 >/= 18 years of age who will undergo elective total hip replacement or total knee replacement and receive Xarelto or other pharmacologic standard of care Venous Thromboembolism (VTE) prophylaxis, and who consent to participate in the study
排除标准
- •Patients with hypersensitivity to any pharmacologic VTE prophylaxis treatment
- •Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
- •Patients with significant hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •Pregnant or lactating women
- •Patients with hereditary problems of lactose or galactose intolerance (e.g., the Lapp lactase deficiency or glucose-galactose malabsorption)
研究组 & 干预措施
Group 1
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Group 2
干预措施: Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.) (Drug)
结局指标
主要结局
Adverse event collection
时间窗: From the start of signed consent to 4 weeks after discharge
次要结局
- Duration of treatment(Whole treatment period)
研究者
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