NCT00395772已完成2 期
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 543
- 主要终点
- The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks.
研究概览
简要总结
The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.
详细描述
Within the U.S., Johnson & Johnson is sponsor.
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
- Double (Participant, Investigator)
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
- •Confirmed acute symptomatic DVT, i.e. proximal or extensive calf-vein thrombosis involving at least the upper third part of the calf veins, without concomitant symptomatic PE
- •Written informed consent
排除标准
- •Legal lower age limitations (country specific)
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- •Other indication for VKA than PE/DVT
- •More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
- •Participation in another pharmacotherapeutic study within the prior 30 days
- •Creatinine clearance < 30 mL/min, impaired liver function (transaminases > 2 x ULN), or bacterial endocarditis
- •Life expectancy < 3 months
- •Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin
- •Uncontrolled hypertension: systolic blood pressure > 200 mmHg and diastolic blood pressure > 110 mmHg
- •Pregnancy or childbearing potential without proper contraceptive measures
- •Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
- •Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study
研究组 & 干预措施
Arm 4
Active Comparator
干预措施: (LMW) Heparin + Vitamin K Antagonist (Drug)
Arm 1
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 2
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
Arm 3
Experimental
干预措施: Xarelto (Rivaroxaban, BAY59-7939) (Drug)
结局指标
主要结局
The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks.
时间窗: 12 weeks
次要结局
- The separate components of the primary efficacy outcome at 12 weeks.(12 weeks)
- The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks.(12 weeks)
研究者
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