NCT00361894已完成3 期
RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee 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
- 2,531
- 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 prevents blood clot which may form after a knee 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
- Prevention
- 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 knee replacement
排除标准
- •Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 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 13+/-4
次要结局
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)(Treatment period: up to Day 13+/-4)
- Incidence of symptomatic VTE (DVT, PE)(Treatment period: up to Day 13+/-4)
- Incidence of DVT (total, proximal, distal)(Treatment period: up to Day 13+/-4)
- Incidence of symptomatic VTE during follow-up(Follow-up period: following 13+/-4 days)
- The composite endpoint comprising major VTE and treatment-emergent major bleeding(For major VTE, treatment period: up to Day 13+/-4 ; 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 13+/-4)
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death(Treatment period: up to Day 13+/-4)
- 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
相似试验
已完成
3 期
Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to EnoxaparinVenous ThromboembolismNCT00329628Bayer4,541
已完成
3 期
Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip ReplacementPreventionVenous ThromboembolismNCT00332020Bayer2,457
已完成
3 期
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.Venous ThromboembolismNCT00362232Bayer3,148
已完成
1 期
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer SubjectsHealthyNCT02170740Boehringer Ingelheim26
已完成
1 期
Multiple Oral Doses of BIBR 1048 MS Solution in Healthy VolunteersHealthyNCT02170831Boehringer Ingelheim40