A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 421
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
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 primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.
The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.
详细描述
Randomization had to take place just prior to the first study drug injection.
The total duration of observation per participant was 35-42 days from randomization broken down as follows:
- 10 to 14-day double-blind treatment period;
- 25 to 32-day follow-up period.
Mandatory bilateral compression ultrasound [CUS] had to be performed between 10 to 15 days after randomization.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:
- •Congestive heart failure (New York Heart Association [NYHA] class III/IV);
- •Acute respiratory failure (not requiring mechanical ventilation);
- •Acute infection (without septic shock)*;
- •Acute rheumatic disorder*;
- •Acute episode of inflammatory bowel disease*.
- •Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:
- •Age ≥ 75 years;
- •Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);
- •Previous VTE;
- •Oral hormone therapy (antiandrogen or estrogen);
- •Chronic heart failure;
- •Chronic respiratory failure.
排除标准
- •Previous surgery with general anesthesia within 30 days before inclusion in the study;
- •Patient requiring a curative anticoagulant or thrombolytic treatment;
- •Patient at risk of bleeding;
- •Known hypersensitivity to heparin or enoxaparin sodium;
- •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 10-14 days
干预措施: Semuloparin sodium (Drug)
Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
干预措施: Enoxaparin sodium (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
时间窗: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
VTE included: * asymptomatic proximal Deep Vein Thrombosis (DVT) detected by the mandatory CUS and confirmed by a Compression Ultrasound Adjudication Committee (CUSAC) after central and blind review of the mandatory CUS; * symptomatic DVT and non-fatal Pulmonary Embolism (PE) reported by the investigator and confirmed by a Central Independent Adjudication Committee (CIAC) after central and blind review of diagnosis tests. VTE-related Death included fatal PE and unexplained deaths.
次要结局
- Percentage of Participants Who Experienced asymptomatic proximal DVT(From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.)
- Percentage of Participants Who Experienced Clinically Relevant Bleedings(From 1st 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 15 days after randomization or the day of mandatory CUS, whichever came first)