The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
264
DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
Unnamed facility
Osaka, Japan
Unnamed facility
Tokyo, Japan
Unnamed facility
Kaohsiung City, Taiwan
Percentage of Subjects With Venous Thromboembolism Events
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. * Lower extremity DVT confirmed by bilateral venography at the end of study treatment * Definite diagnosis of symptomatic PE * Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of VTE
Time frame: 2 weeks
Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings.
Time frame: 2 weeks
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