EUCTR2005-002457-41-DE进行中（未招募）不适用
Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 960
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.Scheduled for elective primary hip replacement
- •2.Age 18 years or over
- •3.Written informed consent obtained
- •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.Documented history of previous venous thromboembolism (VTE) or considered at increased risk of VTE (bed-ridden for longer than 7 days prior to the operation, malignancy, tumors leading to increased risk)
- •2.Subjects considered at increased risk of bleeding:
- •a.known hemorrhagic and thrombotic disorder
- •b.thrombocytopenia, i.e. platelet count < 100x10E+09 g/L
- •c.history of recent clinically important bleeding or major trauma, major surgery, or eye, spinal cord, or brain surgery
- •d.acute bacterial endocarditis
- •e.hypertension stage I, i.e. systolic BP = 159 mmHg and/or diastolic BP > 99 mmHg
- •f.retinopathy
- •g.planned indwelling intrathecal or epidural catheter for more than 6 hours after the end of surgery
- •3.Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
- •4.Concomitant use of anticoagulants/antiplatelet agents
- •5.Hypersensitivity to iodinated contrast media or enoxaparin
- •6.Myocardial infarction or stroke within the last 6 months
- •7.Body weight less than 50 kg
- •8.Abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or estimated creatinine clearance
研究者
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-SEAstellas Pharma Europe B.V.960
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-EEAstellas Pharma Europe B.V.960
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Direct Factor Xa inhibitor YM150 for prevention of venous thromboembolism in patients undergoing elective total hip replacement.A double blind, parallel, dose-finding study in comparison with open label enoxaparin (Study no. 150-CL-008)Protocol for Phase 2B Study of YM150 - ONYX-2Elective primary hip replacement surgeryClassification code 10020096EUCTR2005-002457-41-FIAstellas Pharma Europe B.V.960