Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 302
- 主要终点
- Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
研究概览
简要总结
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 20 years or above
- •Patients undergoing elective TKR (the first replacement of the applicable knee joint)
- •Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance
排除标准
- •Planned, staged major orthopedic surgery within 3 months prior to elective TKR or during this study
- •History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk
- •*: within 3 months prior to elective TKR for gastrointestinal bleeding
- •Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)
- •Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
- •Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
- •Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
- •Planned intermittent pneumatic compression during treatment period.
研究组 & 干预措施
Arm 1
干预措施: Rivaroxaban (BAY59-7939) (Drug)
Arm 2
干预措施: Rivaroxaban (BAY59-7939) (Drug)
Arm 3
干预措施: Rivaroxaban (BAY59-7939) (Drug)
Arm 4
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
时间窗: from the first intake of study medication to no later than 2 days after the last intake of study drug
A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes
时间窗: up to Day 13 (±2 days)
次要结局
- symptomatic venous thromboembolism(within 30 days after stop of treatment with study drug)
- deep vein thrombosis (total, proximal, distal)(up to Day 13 (±2 days))
- major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)(up to Day 13 (±2 days))