A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
研究概览
简要总结
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:
- Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
- Incidence of DVT (total, proximal, distal)
- Incidence of nonfatal PE
- Incidence of symptomatic VTE (DVT, PE)
- VTE caused mortality
- Non-VTE caused mortality
- Incidence of all hemorrhagic complications
- Incidence of major and clinically relevant non-major bleeding
- Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
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
- Double (Participant, 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 or female, age ≥ 18 years;
- •Planned total knee replacement surgery;
- •Signed informed consent form;
- •Willing to comply with the protocol;
- •Willing to use adequate contraception during the trial.
排除标准
- •Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
- •History of venous thrombosis of any location or PE
- •History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
- •History of evident coagulopathy or in a relative
- •Congenital thrombophilia
- •Bleeding within 6 months of screening; increased risk of bleeding
- •BMI less than 18,5 or more than 40 kg/m2
- •Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes
- •Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
- •Platelets < 100 000/mm3
- •Clinical significant abnormalities of APTT and/or INR
- •GFR < 30 ml/min/1.73 m2
- •ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN
研究组 & 干预措施
TeaRx 50 mg
TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days)
干预措施: TeaRx (Drug)
TeaRx 100 mg
TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)
干预措施: TeaRx (Drug)
TeaRx 150 mg
TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)
干预措施: TeaRx (Drug)
Enoxaparin
Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days)
干预措施: Enoxaparin (Drug)
结局指标
主要结局
venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
时间窗: 6 weeks following total knee replacement
Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
时间窗: 6 weeks following total knee replacement
Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
时间窗: 6 weeks following total knee replacement
Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
时间窗: 6 weeks following total knee replacement
Non-VTE caused mortality (efficacy of the selected TeaRx dose)
时间窗: 6 weeks following total knee replacement
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)
时间窗: 6 weeks following total knee replacement
次要结局
- Incidence of bleeding (safety of selected TeaRx dose)(6 weeks following total knee replacement)