Venous Thromboembolism
Conditions
Keywords
YM150, FXa inhibitor, Thrombosis, Anticoagulant, Venous thromboembolism, Arthroplasty, replacement, hip
Brief summary
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects is scheduled for elective primary total hip replacement surgery * Written informed consent obtained before screening
Exclusion criteria
* Subject has history of deep vein thrombosis and/or pulmonary embolism * Subject has a hemorrhagic disorder and/or coagulation disorder * Subject has had clinically important bleeding occurred within 90 days prior to the screening visit * Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia * Subject is receiving anticoagulants/antiplatelet agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall incidence of venous thromboembolism | For 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of individual venous thromboembolism | For 2 weeks |
| Incidence of bleeding events | For 2 weeks |
Countries
Japan, South Korea, Taiwan, Thailand
Outcome results
None listed