NCT02123524已完成3 期
A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 11
- 主要终点
- Safety
研究概览
简要总结
This is a Phase III, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg Superficial Vein Thrombosis (> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy.
详细描述
Patients with symptomatic superficial leg thrombosis will be randomized into two arms, a) rivaroxaban 10mg 1 tablet daily for 45 days or b) placebo to determine if rivaroxaban (10 mg once daily) is an effective and safe treatment for superficial vein thrombosis.
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
- •Symptomatic Superficial Vein Thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound)
排除标准
- •Age <18 years
- •Symptoms >42 days
- •Receiving an anticoagulant for another indication (example: atrial fibrillation) when Superficial Vein Thrombosis started.
- •Superficial Vein Thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or Low Molecular Weight Heparin).
- •Planned treatment of Superficial Vein Thrombosis with a course of anticoagulant therapy.
- •Another indication for anticoagulant therapy (example. Deep Vein Thrombosis, Pulmonary Embolism, atrial fibrillation).
- •Judged to require immediate ligation of the saphenofemoral junction or stripping of thrombosed varicose veins.
- •proximal Deep Vein Thrombosis or Pulmonary Embolism within the past 12 months.
- •Superficial Vein Thrombosis associated with sclerotherapy or an intravenous canula.
- •A high risk of bleeding as evidenced by any of the following:
- •Active bleeding
- •Bleeding within the past 30 days due to a cause that has not fully resolved.
- •Known or expected thrombocytopenia with a platelet count of less than 80,000 x 10 9/L.
- •History of ever having had spontaneous intracranial bleeding, or any intracranial bleeding within the past 3 months.
- •Receiving dual antiplatelet therapy (example. aspirin and clopidogrel).
- •Elevated creatinine level is suspected and creatinine clearance has not been estimated, OR creatinine clearance (Cockcroft-Gault equation) of less than 30 ml/min.
- •Clinically relevant hepatic disease (including Child-Pugh B and C) is known or suspected (example., associated with: International Normalized Ratio >1.7; total bilirubin >2 upper limit of normal; or Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >3 times upper limit of normal).
- •Ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole), Human Immunodeficiency Virus (HIV) -protease inhibitors, or strong Cytochrome P450 3A4 (CYP3A4) inducers due to the potential interaction with rivaroxaban.
- •Pregnant or lactating women, or at risk of becoming pregnant.
- •Life expectancy less than 90 days
- •Patient is unwilling or unable to comply with the protocol (example. unable to attend follow-up visits because of geographic inaccessibility).
- •Participating in a competing clinical investigation and receiving any other investigational agent(s).
研究组 & 干预措施
Rivaroxaban
Experimental
Rivaroxaban 10mg tablet daily for 45 days
干预措施: Rivaroxaban (Drug)
Control
Placebo Comparator
Placebo tablet daily for 45 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety
时间窗: 90 Days
Major bleeding within 90 days.
Efficacy
时间窗: 90 days
"Treatment failure" at 90 days (composite of: treated with non-study anticoagulant therapy; proximal Deep Vein Thrombosis or Pulmonary Embolism; surgery for Superficial Vein Thrombosis).
次要结局
- Efficacy(Baseline, day 7, day 45 and day 90)
- Safety(45 days)
研究者
研究点 (11)
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