Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 60
- 主要终点
- Number of clinically relevant bleedings
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.
详细描述
The general design of the trial is open label between the Rivaroxaban and the reference arm. However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between these two groups and in this initial period, the study is blinded.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women >/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)
排除标准
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- •More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of DVT to randomization
- •Calculated creatinine clearance (CLCR) < 30 mL/min
- •Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
- •Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg
研究组 & 干预措施
Arm 1
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Arm 2
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Arm 3
干预措施: Unfractionated heparin (Drug)
Arm 4
干预措施: Warfarin (Drug)
结局指标
主要结局
Number of clinically relevant bleedings
时间窗: Up to 2 days after last dose
Number of participants with newly onset of symptomatic venous thromboembolism (VTE)
时间窗: Up to 12 months
次要结局
- Number of participants with deterioration in thrombotic burden(Up to 12 months)
- Number of participants with improvement in thrombotic burden(At week 3)
- Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus(Up to 12 months)