Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,100
- 试验地点
- 7
- 主要终点
- Rate of recurrent venous thromboembolism
研究概览
简要总结
The treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. Aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.
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
- 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
- •Objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses).
排除标准
- •Age < 18 years
- •Any absolute contraindication to anticoagulant treatment
- •Pregnancy or breast-feeding
- •Presence of active cancer
- •Concomitant presence of proximal deep vein thrombosis or pulmonary embolism
- •Any concomitant indication for long-term anticoagulant treatment
- •Creatinine clearance ≤30 ml/min, according to Cockcroft-Gault equation
- •Cirrhosis Child-Pugh score B or C
- •Liver disease associated with coagulopathy and high risk of bleeding
- •Any other contraindication to rivaroxaban as per local SmPC
- •Failure to provide written informed consent
研究组 & 干预措施
Rivaroxaban
Rivaroxaban 20 mg od for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks and 20 mg od for 3 weeks)
干预措施: rivaroxaban (Drug)
Placebo
Placebo for 6 weeks after an initial course of rivaroxaban for 6 weeks (15 mg bid for 3 weeks followed by 20 mg od for 3 weeks)
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of recurrent venous thromboembolism
时间窗: 24 months
Recurrent venous thromboembolism defined as new deep vein thrombosis, extension of distal deep vein thrombosis or pulmonary embolism
次要结局
- Rate of cardiovascular events(24 months)
- Rate of major bleeding events(Until 2 days from the last intake of the study drug)
- Rate of clinically relevant non-major bleeding events(Until 2 days from the last intake of the study drug)
- Percentage of patients with residual vein occlusion(3 months and 24 months)
研究者
Walter Ageno
Associate Professor of Medicine
Università degli Studi dell'Insubria