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

Phase 1

Conditions: Elective primary hip replacement surgery
Classification code 10020096

Registration Number: EUCTR2005-002457-41-GR

Lead Sponsor: Astellas Pharma Europe B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 960

Inclusion Criteria

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

Exclusion Criteria

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 < 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.severe hypertension, i.e. systolic BP = 180 mmHg and/or diastolic BP = 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), aspartate aminotransferase (AST), and/or estimated creatinine clearance

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the optimal therapeutic dose by evaluation of the efficacy of YM150 in subjects undergoing elective primary hip replacement (HR) surgery.<br><br>Evaluation of the safety of YM150 in the target population.;Secondary Objective: ;Primary end point(s): Primary efficacy endpoint: <br>- Rate of total venous thromboembolism (VTE) during hospitalization phase (up to Day 7-10) <br> • Deep vein thrombosis (DVT) proven by bilateral venography and/or <br> • Symptomatic DVT and/or <br> • Pulmonary embolism<br><br>Primary safety endpoint: <br>-Incidence of clinically relevant bleedings during 7-10 days hospitalization treatment rated as Major bleeding.

Secondary Outcome Measures

Name	Time	Method

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