Arthroplasty, Replacement, Knee
Conditions
Keywords
Knee Arthroplasty, Factor Xa, VTE, Thrombosis, Anticoagulants
Brief summary
To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery
Interventions
DRUGYM150
Oral
DRUGWarfarin
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for elective primary knee arthroplasty * Written Informed consent obtained
Exclusion criteria
* Subject has documented history of previous VTE * Subject is considered to be at increased risk of VTE * Subject has active bleeding or any condition associated with increased risk of bleeding * Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of total venous thromboembolisms (VTE). | 6 Weeks |
| The incidence of bleeding events classified as major by the Adjudication Committee | 6 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of the bleeding types: major, clinically relevant nonmajor, minor | 6 Weeks |
| Evaluation of efficacy variables including: Proximal VTE, Distal VTE, Confirmed symptomatic VTE, death due to any cause | 6 Weeks |
Countries
Canada, United States
Outcome results
None listed