A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 2,326
- 试验地点
- 3
- 主要终点
- Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or Death From Any Cause
研究概览
简要总结
The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip replacement surgery.
The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip 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
- •Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry.
排除标准
- •Any major orthopedic surgery in the 3 months prior to study start;
- •Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
- •High risk of bleeding;
- •Known allergy to heparin or enoxaparin;
- •Any contra-indications to the performance of venography;
- •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
Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind
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
Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind
干预措施: Placebo (Drug)
Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium
Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind
干预措施: Enoxaparin sodium (Drug)
Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium
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 Death From Any Cause
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 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)