REgulation of Coagulation in ORthopedic Surgery to prevent DVT and PE, controlled, double-blind, randomized study of BAY 59-7939 in the extended prevention of VTE in patients undergoing elective total hip replacement.

INTERVENTION: The patients will be randomized to I treatment group. I. 10 mg od of Bay 59‐7939 tablets active substance (10 mg tablet) from Day 1 to Day 35 plus a placebo syringe of enoxaparin from Day 0 ‐ Day 12 Day 1 will be defined as the day of the elective total hip replacement. On Day 1 the first dose of BAY 59‐7939 or matching placebo and the second dose of enoxaparin or matching placebo will be administered post‐operatively 6‐8 hours after wound closure. Active treatment period for the Enoxaparin arm is day 0 to day 12. The active treatment period for BAY 59‐3979 arm is from Day 1 until day 35. On day 36 a bilateral ascending venography is mandatory for all patients. If symptoms of DVT occur earlier, an ultrasound may be allowed. If the DVT is confirmed by ultrasound, a bilateral ascending venography is mandatory for all patients. No further study medication will be administered after the venography. If symptoms of pulmonary embolism occur during the study (including follow‐up of 30 days post study treatment) a lung scintigraphy with chest X‐Ray or a spiral CT or a pulmonary angiography should be performed. Symptoms of DVT occurring during follow‐up should be verified by ultrasound or venography. CONDITION: Patients undergoing total hip replacement. PRIMARY OUTCOME: The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of: ; ‐ Any DVT (proximal and/or distal) The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of: ; ‐ Death from all causes. The primary efficacy endpoint as assessed by venography, is defined as a composite endpoint of: ; ‐ Non fatal PE SECONDARY OUTCOME: Incidence of DVT (total, proximal, distal). Incidence of symptomatic VTE (DVT, PE). Incidence of symptomatic VTE during follow‐up. Incidence of the composite endpoint comprising proximal DVT, non‐fatal PE and VTE‐related death. Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE related death (composite of proximal DVT and nonfatal PE and death from all causes ). Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT and nonfatal PE and VTE‐related death). INCLUSION CRITERIA: Patients scheduled for elective total hip replacement.‐ Patients’ written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures.