Conditions: Venous Thromboembolism
Keywords: anticoagulant venus thromboembolism thrombosis thromboembolism embolism and thrombosis deep vein thrombosis DU-176b Edoxaban factor Xa total knee arthroplasty Enoxaparin sodium
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 716
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Detailed description:

Arms:
arm 1: DU-176b oral tablets, 30 mg., taken 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.

Interventions: intervention 1: edoxaban intervention 2: enoxaparin sodium
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: