ACTRN12607000222448已完成3 期
The effect of oral direct factor Xa inhibitor rivaroxaban in treating (Bay 59-7939 / 11702) and in the long term prevention (Bay 59-7939 / 11899) in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.
Bayer Australia Limited0 个研究点目标入组 5,193 人开始时间: 2007年4月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,193
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria for Bay 59-7939 / 11702. Confirmed acute symptomatic proximal deep vein thrombosis or confirmed acute symptomatic pulmonary embolism.
- •Active bleeding.Inclusion criteria for Bay 59-7939 / 11899.Confirmed acute symptomatic deep vein thrombosis or pulmonary embolism who have been treated for 6 or 12 months with vitamin K antagonist.
排除标准
- •Exclusion criteria for 11702Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep vein thrombosis (DVT) and/or pulmonary embolism (PE).Other indication for VKA other than DVT and/or PE. More than 36 hours pre-randomisation treatment with therapeutic dosages of low molecular weight heparin / fondaparinux or more than a single dose of VKA prior to randomisation.Significant renal or liver disease.
- •Exclusion criteria for 11899Other indication for VKA other than DVT and/or PE.Significant renal or liver disease.Systolic blood pressure greater than 180 mmHg or diastolic greater than 110 mmHgActive bleeding. Bacterial endocarditis.Active bleeding or high risk for bleeding.Life expectancy less than 3 months.
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