Conditions: Thromboembolism
Keywords: Prevention of Venous Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 215
Healthy volunteers: no

Brief summary:
Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.

Detailed description:
Approximately 200 patients undergoing unilateral knee replacement will be entered into the study and randomized to receive either enoxaparin 30 mg sq bid, PRT054021 15 mg po bid, or PRT054021 40 mg po bid for 10 to 14 days, at which time patients will undergo venography.

Arms:
arm 1: Betrixaban 15 mg oral twice daily for 10 to 14 days arm 2: Betrixaban 40 mg oral twice daily for 10 to 14 days arm 3: Enoxaparin 30 mg administered subcutaneously every 12 hours for 10 to 14 days

Interventions: intervention 1: Betrixaban intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Capsule intervention 2: Administered subcutaneously

Protocol document: