None listed
Conditions
Interventions
Group 1 Type of group
AVE5026 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery (placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind)
Group name:Group 2 Type of group
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium (placebo for AVE5026 8 hours after surgery to maintain the blind)
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Patients undergoing major surgery in the peritoneal and / or retroperitoneal area and / or the minor pelvis (although not limited to the minor pelvis) for indications not related to the liver (including the hepato-biliary system), the uterus or the prostate • Signed Informed Consent. • Patients under 60 years of age should have one of the following additional risk factors: History of VTE, Obesity (BMI> 30 kg / m2), Chronic heart failure, Chronic respiratory failure, Inflammatory Bowel Disease, Oncological surgery
Exclusion criteria
Exclusion criteria: • Limitations by minimum legal age (country specific) • Life expectancy less than 3 months • Known venous pelvic obstruction • Any major general or orthopedic surgery in the 3 months prior to the start of the study • Clinical signs or symptoms of VTE or PET within the last 12 months or known post phlebitic syndrome (the baseline physical examination to be performed prior to surgery will include the systematic evaluation of the signs and symptoms of VTE and will be used to confirm the absence of signs and symptoms of VTE before randomization of the patient in the study) • Known sensitivity to iodine or contrast fluids, and some contraindication to performing venography • Any treatment with other anti-thrombotic agents prior to randomization (5 half-lives according to the respective prescribing information) or planned during the course of the study • Subjects with little probability of complying with the protocol, for example with a non-cooperative attitude, inability to attend follow-up visits, inability to receive daily application (preferably from a Health Professional) after discharge from hospitalization and improbability of completing the study. • Treatment with any research product or device under investigation in the last 30 days or 5 half-lives (if applicable) prior to randomization • Any previous exposure to AVE5026 (eg previous participation in any clinical trial with AVES026) • Major active bleeding • Thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of enoxaparin sodium • Known hypersensitivity to enoxaparin sodium (eg pruritus, urticaria, anaphylactoid reactions) • Known hypersensitivity to heparin or pork products • Pictures with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired coagulation disorders, gastrointestinal active ulcerative and angiodysplastic disease, hemorrhagic stroke or short time after brain, spine or ophthalmologic surgery • End-stage renal impairment (estimated creatinine clearance <10 mL / min [see Appendix C]) or dialysis patients • Pregnant or breastfeeding women • Women of childbearing age, not protected by highly effective contraceptive methods as defined for contraception in the Informed Consent Form during the study term and / or who do not wish or cannot undergo pregnancy tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:VTE includes any proximal or distal Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths includes fatal PE and deaths for other reason than PE. Measure:Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death Timepoints:rom randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:major VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC. Measure:Percentage of Participants Who Experience major VTE or All-cause Death Timepoints:From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first ; Outcome name:Bleedings are centrally and blindly reviewed by the CIAC and classified as: -major (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation); -clinically relevant non-major (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by health care professional); -Nonclinically relevant bleeding. Measure:Percentage of Participants Who Experience Clinically Relevant Bleedings (major and clinically relevant non-major bleedings ) Timepoints:From 1st study drug injection up to 3 days after last study drug injection ; Outcome name:Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigators answer to the question was the subject treated for VTE? asked after the diagnostic tests for suspected VTE and after the mandatory venography. Measure:Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment Timepoints:From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, India, Italy, Korea South, Latovia, Lithuania, Mexico, New Zealand, Norway, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactFlor Luna
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed