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 - 150-CL-008

ASTELLAS PHARMA0 个研究点目标入组 960 人开始时间: 2006年10月31日最近更新: 2012年5月1日

试验速览

暂无简介。

•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

•1. Documented history or considered at increased risk of venous thromboembolism 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 disorder b. thrombocytopenia, i.e. platelet count 100x109 /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. severe hypertension, i.e. systolic BP 8805; 180 mmHg and/or diastolic BP 8805; 110 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 and/or aspartate aminotransferase AST , and/or estimated creatinine clearance

发起方