EUCTR2005-001388-71-AT进行中（未招募）不适用
A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis.Protocol version 3.0 dated 29-June-2005 - Botticelli
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 660
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
- •1) Confirmed acute symptomatic DVT, i.e., proximal or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation area) without concomitant symptomatic PE
- •2) Written informed consent.
- •3) Women who are not of childbearing potential (i.e. who are post-menopausal or surgically sterile) and men ages 18( or legal age of consent) to 90.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Legal lower age limitations (country specific)
- •2) Women of childbearing potential or who are pregnant or breast feeding
- •3) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
- •4) Indications for VKA other than DVT
- •5) More than 24 hours pre-randomization treatment with therapeutic dosages of UFH, LMWH or fondaparinux or more than a single starting dose of VKA prior to randomization
- •6) Participation in another pharmacotherapeutic study within 30 days
- •7) Creatinine clearance < 30 ml/min, impaired liver function (ALT > 3 x ULN), or bacterial endocarditis
- •8) Life expectancy <6 months
- •9) Active bleeding or high risk for bleeding contraindicating treatment with LMWH, fondaparinux or VKA
- •10) Systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg
- •11) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •12) Any other contraindication listed in the local labeling of warfarin, acenocoumarol, phenprocoumon, fondaparinux, enoxaparin, or tinzaparin
- •13) Use of acetylsalicylic acid (ASA) > 165 mg/day.
研究者
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