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.

The patients will be randomized to I treatment group. I. 10 mg od of Bay 59-7939 tablets active substance (10 mg tablet) plus a placebo syringe of enoxaparin (one tablet in the evening plus one s.c. injection in the evening) The treatment period is day 0 to day 35. Day 0 is defined as the day prior elective hip replacement. On day 0 the first dose of enoxaparin or matching placebo will be given. Day 1 will be defined as the day of the elective total hip replacement. In the evening of the surgery, BAY 59-7939 or matching placebo tablets will be administered orally. Thereafter, BAY 59-7939 or matching placebo tablets will be given once daily every 24 hours until day of venography (day 36). Last dose of BAY 59-7939 or matching placebo will be administered in the evening prior to venography. Enoxaparin 40 mg or matching placebo will be administered subcutaneously in the evening of the surgery, thereafter once daily in the evening according to the hospital routine. 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.