Health Condition 1: null- Abdominal surgery, Venous Thromboembolism
Conditions
Interventions
Intervention1: Drug: AVE5026: Once daily subcutaneous injection for 7 to 10 days after surgery
Control Intervention1: Drug: Enoxaparin: Once daily subcutaneous injection for 7 to 10 days after surgery
Sponsors
SanofiSynthelabo India Limited
Eligibility
Inclusion criteria
Inclusion criteria: "Inclusion Criteria: Patients undergoing major surgery in the peritoneal and/or the retroperitoneal space and/or the pelvis minor (but not limited to the pelvis minor) for indications other than limited disease of the liver (including hepatobiliary system), the uterus, or the prostate Patients with an age of  History of VTE  Obesity (BMI ≥30 kg/m2)  Chronic Heart Failure  Chronic Respiratory Failure  Inflammatory Bowel Disease  Cancer Surgery Signed informed consent "
Exclusion criteria
Exclusion criteria: "Exclusion Criteria: 1. Legal lower age limitations (country specific) 2. Life expectancy less than 3 months 3. Known pelvic venous obstruction 4. Any major orthopedic or general surgery in the 3 months prior to study start 5. Clinical signs or symptoms of DVT or PE within the last 12 months or known postphlebitic syndrome 6. Known sensitivity to iodine or contrast dyes, and any contraindications to the performance of venography 7. Any treatment or procedure with other antithrombotic agents within 2 weeks prior to randomization or planned during the course of the study treatment period that could affect the incidence of VTE, such as: &#61485; Parenteral anticoagulants (unfractionated heparin (UFH), LMWH [eg, enoxaparin, dalteparin, nadroparin...], fondaparinux, bivalirudin, hirudin) &#61485; Oral anticoagulants (eg, vitamin K antagonists) &#61485; GPIIb/IIIa antagonists: abciximab, eptifibatide, tirofiban &#61485; Thrombolytic agents &#61485; Dextrans &#61485; Intermittent pneumatic compression of the legs (IPC) 8. Subject unlikely to comply with protocol, eg, uncooperative attitude, inability to return for follow up visits, inability to receive daily injection (preferably by a Health Care Professional) after hospital discharge, and unlikelihood of completing the study 9. Treatment with any investigational product or investigational device in the last 30 days or 5 half lives (whichever is longer) prior to randomization. 10. Any previous exposure to AVE5026 (eg, participation in any previous AVE5026 clinical trial) Exclusion criteria related to enoxaparin 11. Active major bleeding 12. Thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of enoxaparin sodium 13. Known hypersensitivity to enoxaparin sodium (eg, pruritus, urticaria, anaphylactoid reactions) 14. Known hypersensitivity to heparin or pork products 15. Conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery. Exclusion criteria related to AVE5026 16. End stage renal disease (estimated creatinine clearance <10 mL/min [see Appendix C]) or patient on dialysis 17. Pregnant or breastfeeding women 18. Women of childbearing potential not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form for the duration of the study and/or who are unwilling or unable to be tested for pregnancy."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of any VTE and death from any cause Timepoint: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Individual Components of the primary outcome measure Timepoint: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, India, Italy, Latvia, Lithuania, New Zealand, Norway, Peru, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactKoushik Ganguly
Outcome results
None listed