None listed
Conditions
Interventions
This group will be treated with BAY 59-7939 10 mg PO QD from day 1 to day 35 ± 4 + Enoxaparin Placebo SC QD from day 0 to day 12 ± 2.
Group name:GROUP 2 Type of group
This group will be treated with BAY 59-7939 Placebo QD from day 1 to day 35 ± 4 + Enoxaparin 40 mg SC QD from day 0 to day 12 ± 2.
GROUP 1 Type of group
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients older than 18 years. 2. Patients scheduled for total hip replacement. 3. Written informed consent of patient participation after receiving detailed written and verbal information before any specific procedure of the study.
Exclusion criteria
Exclusion criteria: 1. Total bilateral hip replacement in planned phases. 2. Active bleeding, or high risk of bleeding for which treatment with low molecular weight heparin is contraindicated. 3. Contraindication listed on the label or conditions that prevent the patient from being treated with enoxaparin. 4. Conditions in which bilateral phlebography is prohibited. 5. Women breastfeeding or pregnant. Women with pregnancy potential who are not using an adequate contraceptive method. 6. Drug or alcohol abuse. 7. Concomitant use of protease inhibitors-HIV 8. Therapy with another research product within 30 days prior to the start of the study. 9. Intermittent pneumatic compression planned during the active period of treatment. 10. Concomitant participation in another test or study. 11. Other concomitant medications not allowed. 12. Be on oral anticoagulant therapy that can not be stopped.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs of DVT / TP. Bilateral venography of lower limbs. Ventilation / perfusion lung scintigraphy combined with a chest x-ray, or spiral CT, or pulmonary angiography. Measure:Efficacy of treatment: Compounded by 1) any proximal and / or distal deep vein thrombosis (DVT). 2) Non-fatal pulmonary thromboembolism (TP). 3) Death for all causes. Timepoints:Clinical evaluation of signs of DVT / PD: Days 1, 6 ± 2, 13 ± 2, 36 ± 4 and 65 + 5. Bilateral bilateral venography: Days 36 ± 4. Ventilation / perfusion lung scintigraphy combined with a chest x-ray, or a spiral CT, or a pulmonary angiography: At the time of suspected PT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of signs of DVT / TP. Bilateral phylography of lower limbs. Ventilation / perfusion lung scintigraphy combined with a chest x-ray, or spiral CT, or pulmonary angiography. Measure:1) Incidence of the composite endpoint comprising: Proximal DVT + Non-fatal PE + Death related to VTE 2) Incidence of the composite endpoint comprising: Proximal DVT + Non-fatal PE + Death for all causes. 3) Incidence of the composite endpoint comprising: Proximal DVT + non-fatal PE + Death by DVT and non-fatal PE. 4) Incidence of symptomatic VTE. 5) Incidence of DVT. 6) Incidence of symptomatic VTE during follow-up. Timepoints:Clinical evaluation of signs of DVT / PD: Days 1, 6 ± 2, 13 ± 2, 36 ± 4 and 65 + 5. Bilateral bilateral phlebography: Days 36 ± 4. Ventilation / perfusion lung scintigraphy combined with a chest x-ray, or a spiral CT, or a pulmonary angiography: At the time of suspected PT. ; Outcome name:Clinical evaluation: of major or minor bleeding, of other adverse events, deaths. Surgical clinical evaluation: Determination of amount of blood loss, volume drained. Laboratory tests: Hematology panels, serum chemistry, coagulation parameters Measure:Safety of treatment: 1) Incidence of major bleeding that arises with the treatment no later than 2 days after the last dose of the study pharmaceutical product. 2) Incidence of any bleeding that arises with the treatment observed no later than 2 days after the last dose of the studys pharmaceutical product. 3) Incidence of any postoperative bleeding (greater or not greater). 4) Adverse events that arise with the treatment. 5) Serious adverse events that arise with the treatment. 6) Deaths. 7) Adverse events that begin more than 7 days after stopping treatment. 8) Major cardiovascular events. 9) Incidence of hospitalization. 10) Transfusion requirement. 11) Amount of intraoperative blood loss. 12) Drained postoperative volume. 13) Laboratory parameters. Time | — |
Countries
Australia, Brazil, Canada, China, Colombia, Denmark, Estonia, India, Indonesia, Italy, Korea South, Latovia, Lithuania, Mexico, New Zealand, Norway, Portugal, South Africa, Sweden, Taiwan, United Kindgdom, United States
Outcome results
None listed