An Efficacy and Safety Study of Ribaroxaban for the Prevention of Deep Vein Thrombosis Recurrence in Patients With Acute Iliofemoral Venous Thrombosis Initially Treated With Thrombolysis
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- recurrence rate
研究概览
简要总结
The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis patients and FDA approved the rivaroxaban for prevention and treatment of deep vein thrombosis (Nov 2 2012).
Recently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome, and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e, iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis if they had been treated with a vena cava filter or a fibrinolytic agent for the current episode of thrombosis.
Although catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24 hours after thrombolysis will be included in this study.
Also, the investigators want to explore the efficacy and safety of rivaroxaban in patients with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion and/or venous stent insertion and compare these outcomes with warfarin treatment alone.
This study will be a pilot study to establish the safety and efficacy parameters for further studies.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Onset of symptoms within the past 21 days
- •Objectively verified (by CT venography) deep vein thrombosis localized in the iliofemoral segment
- •Complete catheter-directed thrombolysis and/or a vena cava and/or venous stent insertion
- •Informed consent
排除标准
- •Incomplete catheter-directed thrombolysis
- •If patients received more than a single dose of a warfarin before randomization
- •contraindicating anticoagulant treatment
- •another indication for a warfarin
- •an estimated glomerular filtration rate by MDRD equation <30ml/min
- •clinically significant liver disease (acute hepatitis, chronic active hepatitis, cirrhosis)
- •Alanine aminotransferase > 3-time higher than upper limit of the normal range
- •Bacterial endocarditis
- •Active bleeding or high risk of bleeding
- •Pregnancy or breast-feeding
- •Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers
研究组 & 干预措施
rivaroxaban
Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months
干预措施: rivaroxaban (Drug)
warfarin
Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months
干预措施: Warfarin (Drug)
结局指标
主要结局
recurrence rate
时间窗: six month
to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis
次要结局
- vascular events(six months)
研究者
Seung-Kee Min
Professor
Seoul National University Hospital