Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
Phase 2
Completed
- Conditions
- Thromboembolism
- Registration Number
- NCT00353678
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1141
Inclusion Criteria
- Scheduled for elective primary hip replacement
- Age 18 years or over
- Written informed consent obtained
Exclusion Criteria
- Documented history or considered at increased risk of venous thromboembolism
- Subjects considered at increased risk of bleeding
- Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
- Concomitant use of anticoagulants/ antiplatelet agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of total venous thromboembolism (VTE) during hospitalization phase Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
- Secondary Outcome Measures
Name Time Method Incidence of the bleeding types: Rate of total VTE Proximal or distal deep vein thrombosis (DVT) during hospitalization phase Symptomatic VTE Death due to any cause during treatment Major or clinically relevant non-major bleeding, Major bleeding, Clinically relevant non-major bleeding, Minor bleeding