EUCTR2016-000958-36-IT进行中（未招募）1 期
RIDTS Study - Rivaroxaban for the treatment of symptomatic Isolated Distal deep vein Thrombosis - RIDTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of thrombosis in one or more infra-popliteal deep veins of the leg (including distal thromboses that reach the trifurcation area or the muscular ones). Diagnosis should be made by an ultrasonographic study extended to the whole deep vein system of both legs.
- •Patients are eligible only if the diagnosis of IDDVT was obtained 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 LMWH: 6 doses; of fondaparinux: 3 doses).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 550
排除标准
- •1.Age < 18 years
- •2.Any absolute contraindication to anticoagulant treatment
- •3.Pregnancy or breast-feeding
- •4.Presence of active cancer
- •5.Concomitant presence of proximal DVT or pulmonary embolism
- •6.Any concomitant indication for long-term anticoagulant treatment
- •7.Creatinine clearance =30 ml/min, according to Cockcroft-Gault equation
- •8.Cirrhosis Child-Pugh score B or C
- •9.Liver disease associated with coagulopathy and high risk of bleeding
- •10.Any other contraindication to rivaroxaban as per local SmPC
- •11.Failure to provide written informed consent
研究者
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