A Multinational, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of Semuloparin (AVE5026) With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,150
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or All-cause Death
研究概览
简要总结
The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective knee replacement surgery.
The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.
详细描述
Randomization had to take place just prior the first study drug injection (randomization ratio 1:1).
The total duration of observation per participant was 35-42 days from surgery broken down as follows:
- 7 to 10-day double-blind treatment period;
- 28 to 35-day follow-up period.
Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.
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
- •Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry.
排除标准
- •Any major orthopedic surgeries in the 3 months prior to study;
- •Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
- •Any contraindications to the performance of venography;
- •High risk of bleeding;
- •Know allergy to heparin, or enoxaparin, or pork products;
- •End stage renal disease or patient on dialysis.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Semuloparin
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery
To maintain the blind, placebo for Enoxaparin sodium:
- 12 and 24 hours after surgery, then once daily if no SRI
- 12 hours after surgery only if SRI
干预措施: Semuloparin sodium (Drug)
Semuloparin
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery
To maintain the blind, placebo for Enoxaparin sodium:
- 12 and 24 hours after surgery, then once daily if no SRI
- 12 hours after surgery only if SRI
干预措施: Placebo (Drug)
Enoxaparin
Enoxaparin sodium 30 mg twice daily (20 mg once daily if Severe Renal Impairment [SRI]) for 7-10 days with an initial dose given 12 hours after surgery
Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind
干预措施: Enoxaparin (Drug)
Enoxaparin
Enoxaparin sodium 30 mg twice daily (20 mg once daily if Severe Renal Impairment [SRI]) for 7-10 days with an initial dose given 12 hours after surgery
Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or All-cause Death
时间窗: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
VTE included any proximal or distal Deep Vein Thrombosis \[DVT\] (symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after central and blind review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
次要结局
- Percentage of Participants Who Experienced "Major" VTE or All-cause Death(From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first)
- Percentage of Participants Who Experienced Clinically Relevant Bleedings(From first study drug injection up to 3 days after last study drug injection)
- Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment(From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first)