Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 1,452
- 试验地点
- 48
- 主要终点
- symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
研究概览
简要总结
Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed acute symptomatic DVT
- •Written informed consent
排除标准
- •Legal lower age limitations
- •Patients with symptomatic pulmonary embolism
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- •Other indication for VKA than DVT
- •More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
- •Participation in another pharmacotherapeutic study within the prior 30 days
- •Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis
- •Life expectancy <3 Months
- •Active bleeding or high risk for bleeding
- •Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.
- •Pregnancy or childbearing potential without proper contraceptive measures
- •Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin
结局指标
主要结局
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
次要结局
- symptomatic recurrent PE/DVT within 6 months.