RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects 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
- 3,148
- 主要终点
- Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population
研究概览
简要总结
The purpose of this study is to assess if 10 mg BAY59-7939, 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
- Triple (Participant, Care Provider, Investigator)
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 Low Molecular Weight Heparin (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
Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))
Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Enoxaparin 30 mg twice a day (bid)
Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population
时间窗: Up to 16 days after surgery
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.
时间窗: Up to 16 days after surgery
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
次要结局
- Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.(Up to 16 days after surgery)
- The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit(Up to 47 days after surgery)
- Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.(Up to 16 days after surgery)
- Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.(Up to 16 days after surgery)
- Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.(Up to 16 days after surgery)
- Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE(Up to 16 days after surgery)
- Incidence of DVT (Proximal, Distal) Per Protocol Population.(Up to 16 days after surgery)
- Incidence of Symptomatic VTE During Follow-up Per Protocol Population.(Up to 47 days after surgery)
- Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.(Up to 16 days after surgery)
- Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.(Up to 16 days after surgery)
- Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.(Up to 16 days after surgery)
- Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.(Up to 47 days after surgery)
- Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.(Up to 16 days after surgery)
- Treatment-emergent Major Bleedings Per Safety Population.(from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).)