Arthroplasty, Replacement, Hip, Venous Thromboembolism
Conditions
Keywords
Elective hip replacement surgery, Factor Xa, Venous Thromboembolism, Thrombosis, Anticoagulants, Prevention, YM150
Brief summary
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.
Interventions
DRUGYM150
oral
DRUGenoxaparin
SC injection
Sponsors
Astellas Pharma Europe B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for elective hip replacement surgery
Exclusion criteria
* Subject has active bleeding or any condition associated with increased risk of bleeding * Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study * Subject has had an MI or stroke within 3 months before planned hip replacement surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic Venous Thromboembolisms and death from all causes | 12 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all Venous Thromboembolic events | Until day 12, during the treatment period, follow-up period and entire study period |
| Incidence of Bleeding events | During the treatment period, follow-up period and entire study period |
Countries
Australia, Austria, Bosnia and Herzegovina, Brazil, Canada, Colombia, Czechia, Denmark, Estonia, Finland, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Norway, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
Outcome results
None listed