A Randomized, Active-comparator-controlled, Multicenter Study to Assess the Safety and Efficacy of Different Doses of BAY1213790 for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Primary Total Knee Arthroplasty, Open-label to Treatment and Observer-blinded to BAY1213790 Doses
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 813
- 试验地点
- 54
- 主要终点
- Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
研究概览
简要总结
This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.
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
- •Patients aged ≥18 years and undergoing elective primary, unilateral Total Knee Arthroplasty (TKA)
- •Women of non-childbearing potential
排除标准
- •High risk for clinically significant bleeding
- •Prior deep vein thrombosis
- •Body weight above 135 kg
- •Creatinine clearance below 60 ml/min
- •Recent (<6 months) myocardial infarction or ischemic stroke
- •Contraindication listed in the local label of the comparator treatments
- •Requirement for full dose anticoagulation or dual antiplatelet therapy
研究组 & 干预措施
Enoxaparin
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received enoxaparin for at least 10 days until venography was performed.
干预措施: Enoxaparin (Drug)
Apixaban
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received apixaban for at least 10 days until venography was performed.
干预措施: Apixaban (Drug)
BAY1213790 0.3 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once post-surgery.
干预措施: BAY1213790 (Drug)
BAY1213790 0.6 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.6 mg BAY1213790 once post-surgery.
干预措施: BAY1213790 (Drug)
BAY1213790 1.2 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.2 mg BAY1213790 once post-surgery.
干预措施: BAY1213790 (Drug)
BAY1213790 1.8 mg/kg (post-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once post-surgery.
干预措施: BAY1213790 (Drug)
BAY1213790 0.3 mg/kg (pre-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 0.3 mg BAY1213790 once pre-surgery.
干预措施: BAY1213790 (Drug)
BAY1213790 1.8 mg/kg (pre-surgery)
Adult patients who underwent Total Knee Arthroplasty (TKA) surgery and received 1.8 mg BAY1213790 once pre-surgery.
干预措施: BAY1213790 (Drug)
结局指标
主要结局
Incidence of composite endpoint consisting of asymptomatic DVT as detected by mandatory bilateral venography, objectively confirmed symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded
时间窗: Up to 15 days
DVT - Deep vein thrombosis / PE - Pulmonary embolism All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
Incidence of composite endpoint of major and clinically relevant non-major bleeding
时间窗: Up to 15 days
All suspected events were reviewed and classified by the Central Independent Adjudication Committee.
次要结局
- Incidence of composite endpoint of symptomatic DVT, non-fatal PE, fatal PE, unexplained death for which PE cannot be excluded up to Day 157 or objectively confirmed asymptomatic DVT up to Day 15(Up to 157 days)
- Incidence of composite endpoint of major and clinically relevant non-major bleeding(Up to 157 days)