NCT00332020已完成3 期
RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,457
- 主要终点
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
研究概览
简要总结
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 and female patients aged 18 years or above
- •Patients scheduled for elective total hip replacement
排除标准
- •Planned, staged total bilateral hip replacement
- •Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- •Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- •Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Rivaroxaban (BAY59-7939) (Drug)
Arm 2
Active Comparator
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
时间窗: Treatment period: up to day 35+/-6
次要结局
- Incidence of symptomatic VTE during follow-up(Follow-up period: following 35+/-6 days)
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)(Treatment period: up to day 35+/-6)
- Incidence of symptomatic VTE (DVT, PE)(Treatment period: up to day 35+/-6)
- Incidence of DVT (total, proximal, distal)(Treatment period: up to day 35+/-6)
- The composite endpoint comprising major VTE and treatment-emergent major bleeding(For major VTE, treatment period: up to Day 35+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication)
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death(Treatment period: up to day 35+/-6)
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death(Treatment period: up to day 35+/-6)
- Treatment-emergent major bleedings(From first dose of double-blind study medication to up to two days after last dose of double-blind study medication)
研究者
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