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

Astellas Pharma Europe B.V.0 个研究点目标入组 960 人开始时间: 2006年5月24日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•1.Documented history of previous venous thromboembolism (VTE) or considered at increased risk of VTE
•a. bed-ridden for longer than 7 days prior to the operation
•b. malignancy currently under cytostatic or cytotoxic treatment or being the reason for hip replacement
•c. tumors leading to increased risk
•2.Subjects considered at increased risk of bleeding:
•a.known hemorrhagic 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 within 3 months prior to the planned surgery
•d.acute bacterial endocarditis
•e.severe hypertension, 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

发起方