Health Condition 1: I824- Acute embolism and thrombosis of deep veins of lower extremity Health Condition 2: null- Venous Thromboembolsim
Conditions
Interventions
Intervention1: AVE5026: AVE5026 -once daily subcutaneous injection during 3 weeks following initial treatment
Control Intervention1: Placebo: Placebo -once daily subcutaneous injection during 3 week
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Hip fracture surgery
Exclusion criteria
Exclusion criteria: - Any major orthopedic surgery within 3 months prior to enrolment - Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome - Patient at high risk of bleeding - Known hypersensitivity to heparins - Any contraindication to the performance of venography - Permanent discontinuation of AVE5026 during the run-in phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of any VTE and death from any causeTimepoint: From randomization up to the day of a venous thromboembolic event or the day of the mandatory venography, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of any proximal deep vein thrombosis, symptomatic distal deep vein thrombosis, non-fatal pulmonary embolism and all-cause deaths Safety:bleeding events, transfusions, laboratory data, adverse events,deaths Timepoint: From randomization up to the day of a venous thromboembolic event or the day of the mandatory venography, whichever comes first. | — |
Countries
Belarus, Brazil, Canada, Chile, China, Colombia, Egypt, India, Lithuania, Mexico, Peru, Russian Federation, South Africa, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Josemund Menezes
Outcome results
None listed