Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement
Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase II study (ODIXa-OD.HIP - Study 11527).
Inclusion Criteria:
Exclusion Criteria:
Planned, staged major orthopedic surgery within 3 months prior to elective THR or during this study
History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding*), or high bleeding risk
*: within 3 months prior to elective THR for gastrointestinal bleeding
Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: <30 mL/min)
Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
Planned intermittent pneumatic compression during treatment period
Nerima-ku, Tokyo 177-8521, Japan