None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with BAY 59-7939 10 mg, PO, QD, at night, + Enoxaparin Placebo according to the locally authorized regimen: 40 mg SC, QD, at night, or 30 mg SC, IDB. This scheme will be administered for 12 ± 2 days, being day 0 the day before the elective surgery of total knee replacement.
Group name:GROUP 2 Type of group
This group will be treated with BAY 59-7939 Placebo, PO, QD, at night, + Enoxaparin according to the locally authorized regimen: 40 mg SC, QD, at night, or 30 mg SC, BID. This scheme will be administered for 12 ± 2 days, being day 0 the day before the elective surgery of total knee replacement.
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women 18 years of age or older 2. Subjects scheduled for elective surgery of total knee replacement 3. Obtain informed consent in writing from the patient after receiving detailed written and oral information about any specific procedure of the study.
Exclusion criteria
Exclusion criteria: 1. Active bleeding or high risk of hemorrhage as a contraindication to treatment with low molecular weight heparin. 2. Contraindication cited in the package leaflet or conditions that make it impossible to treat the patient with enoxaparin. 3. Conditions that make bilateral phlebography impossible. 4. Pregnant or lactating women. Women of childbearing age who do not use an adequate contraceptive method. 5. Drug or alcohol abuse. 6. Concomitant use of HIV protease inhibitors. 7. Treatment with another product under investigation in the 30 days prior to the start of the study. 8. Intermittent pneumatic compression provided during the treatment period. 9. Simultaneous participation in another trial or study. 10. Other concomitant treatments not allowed. 11. Subjects to whom the anticoagulant therapy can not be interrupted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Diagnosis of DVT: Ultrasound and bilateral phlebography of lower limbs evaluated by the hospital radiologist and the central evaluation unit. 2) Diagnosis of PE: If symptoms of PE are observed, pulmonary angiography or lung perfusion / ventilation scintigraphy should be performed along with a chest x-ray or spiral CT scan. 3) Death due to any cause: Clinical evaluation. Measure:Main primary efficacy: Composed by the sum of the following criteria 1) Any DVT (proximal and / or distal). 2) Non-fatal EP. 3) Death due to any cause. Timepoints:Ultrasound: At the time that signs of DVT appear. Phlebography: When there is a positive ultrasound for DVT and on day 13 ± 2. Angiography, pulmonary perfusion / ventilation scintigraphy, radiography, chest CT scan: When signs of PD are presented. Clinical evaluation: At the moment of an event. ; Outcome name:The severe hemorrhagic episode will be defined according to clinical criteria, and evaluation of the report of the surgical intervention and anesthesia, laboratory results, number of transfusions, hospital reports, summary of the hemorrhagic episode, radiological findings, etc. will be required. In case a patient dies, an autopsy should be performed if possible. Measure:Main safety: Incidence of severe bleeding episodes during treatment up to 2 days after the last administration of the study medication. Timepoints:Within 2 days after the surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:DVT diagnosis: Ultrasound and bilateral phlebography of lower limbs evaluated by the hospital radiologist and the central evaluation unit. Diagnosis of PD: If symptoms of PD are observed, pulmonary angiography or lung perfusion / ventilation scintigraphy should be performed along with a chest x-ray or spiral CT scan. Death due to any cause or related to VTE: Clinical evaluation. Measure:1. Incidence of severe VTE consisting of: proximal DVT + non-fatal PE + death related to VTE. 2. Incidence of the combined endpoint obtained from DVT (proximal and / or distal) + non-fatal EP + death related to VTE. 3. Incidence of the combined criterion obtained from proximal DVT + non-fatal PE + Death due to any cause. 4. Incidence of symptomatic VTE (DVT, PE). 5. Incidence of DVT (total, proximal, distal). 6. Incidence of symptomatic VTE during follow-up. Timepoints:Ultrasound: At the time that signs of DVT appear. Phlebography: When you have a positive ultrasound for DVT and on day 13 ± 2. Angiography, pulmonary perfusion / ventilation scan, radiography, chest CT scan: When signs of PD are present. Clinical evaluation: At the moment of an event. ; Outcome name:The bleeding episodes and their severity will be defined according to clinical criteria, and evaluation of the report of the surgical intervention and anesthesia, laboratory results, number of transfusions, hospital reports, summary of the hemorrhagic episode, radiological findings, etc. will be required. In case a patient dies, an autopsy should be performed if possible. Measure:1) Incidence of any type of hemorrhagic episode during the treatment and up to 2 days after the last dose. 2) Incidence of non-severe bleeding episodes during treatment and up to 2 days after the last dose. 3) Incidence of hemorrhagic episodes in the postoperative period (of any type, serious or not). Timepoints:Within 2 days after the surgery. ; Outcome name:The AA and AAG will be | — |
Countries
Belgium, Czech Republic, Germany, Italy, Norway, Peru, Spain, Sweden
Outcome results
None listed