NCT00062803已完成3 期
The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 试验地点
- 137
- 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 a pulmonary embolism (blood clot in the lung) 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, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.
Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
- •Written informed consent
排除标准
- •Legal lower age limitations (country specific)
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- •Other indication for VKA than PE/DVT
- •More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
- •Participation in another pharmacotherapeutic study within the prior 30 days
- •Creatinine clearance <10 mL/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 or diastolic blood pressure >110 mm Hg
- •Pregnancy or childbearing potential without proper contraceptive measures or women who are breastfeeding
- •Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, 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.
研究者
研究点 (137)
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