Conditions: Venous Thromboembolism Thromboembolism Thrombosis Embolism and Thrombosis Deep Vein Thrombosis Arthroplasty, Replacement, Hip
Keywords: prevention venous thromboembolism edoxaban anticoagulants
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 264
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery arm 2: Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery arm 3: DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery

Interventions: intervention 1: DU-176b 15mg intervention 2: DU-176b 30mg intervention 3: Enoxaparin sodium 20 mg (=2000IU)
Intervention descriptions: intervention 1: DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery. intervention 2: DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery. intervention 3: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.

Protocol document: