None listed
Conditions
Interventions
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 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.
Sponsors
Bayer Australia Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Planned, staged total bilateral hip replacement.- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin.- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin.- Conditions prohibiting bilateral venography (amputation of one leg, allergy to contrast media).- Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. - Drug or alcohol abuse.- Concomitant use of HIV-protease inhibitors.- Therapy with another investigational product within 30 days prior start of study.- Planned intermittent pneumatic compression during active treatment period.- Concomitant participation in another trial or study.- Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator.
Outcome results
None listed