None listed
Conditions
Interventions
Group 1 Type of group
If the estimated creatinine clearance is> 30 mL / min, 20 mg of AVE5026 will be administered. If the estimated creatinine clearance is 30 mL / min, 40 mg of enoxaparin will be administered. If the estimated creatinine clearance is
Subcutaneous diary for 7-10 days
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Elective surgery of total hip replacement or a review of at least one component of a previously implanted total hip prosthesis performed> 6 months prior to entry into the study. Either, planned in the following 12 ± 1 hours OR performed just 8 ± 1 hours before (from the moment of closure of the incision) and having established hemostasis. • Written informed consent signed
Exclusion criteria
Exclusion criteria: • Legal limitations due to minority (specific to the country) • Any major orthopedic surgery in the 3 months prior to the start of the study • elective hip surgery only with change of the polyethylene liner • First phase of a two-stage exchange arthroplasty due to infection after the replacement of a hip prosthesis • Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome • Known sensitivity to iodine or contrast media and any contraindication to the performance of venography • Any treatment with other antithrombotic agents within 2 weeks prior to random or planned assignment during the course of the study, such as: - Parenteral anticoagulant (UFH, LMWH [eg enoxaparin, dalteparin, nadroparin, ....], - Oral anticoagulants (vitamin K antagonists) - GPIIb / IIIa antagonists: abciximab, eptifibatide, tirofiban - Thrombolytic agents • Progressive malignant disease known • Subjects with low probability of complying with the protocol, ex. non-cooperative attitude, inability to return to follow-up visits, inability to receive daily injection by a Health Care Professional after hospital discharge, and improbability to complete the study • Treatment with any product or research device in the last 30 days or 5 half lives (if relevant) prior to the random assignment • Any prior exposure to AVE5026 (ie, participation in any previous AVE5026 clinical study) • 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, anaphylactic reactions) • Known hypersensitivity to heparin or pork products • Conditions with an elevated risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, angiodisplastic and active ulcerative gastrointestinal disease, hemorrhagic attack, or shortly after a brain, vertebral or ophthalmologic surgery. • End-stage renal disease (estimated creatinine clearance <10 ml / min [see Appendix B]) or patients on dialysis • Pregnant or lactating women • Women with pregnancy potential not protected by an effective contraceptive method of birth control according to the definition of contraception in the Informed Consent Form for the duration of the study and / or those who do not wish or are not able to do a test of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:At the time that the Investigator requests diagnostic tests for VTE, these will be done, an award package will be prepared and sent to the CIAC. Prior to any diagnostic test for VTE, a systematic evaluation of the signs and symptoms of VTE will be performed. Measure:The composition of any VTE confirmed by the Independent Central Adjudication Committee (CIAC) and deaths from any cause reported during the efficacy evaluation period. Timepoints:The efficacy evaluation period lasts from the day of the random assignment to the day of a VTE confirmed by the CIAC, or until the day of the mandatory bilateral venography (Day 7 - Day 11), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A symptomatic distal DVT will be defined as a distal DVT confirmed by appropriate diagnostic tests and associated with signs and symptoms consistent with VTE. A systematic tracking of signs and symptoms will be performed for VTE prior to any diagnostic test for VTE. Measure:The composite of the following endpoints recorded during the efficacy evaluation period: any proximal DVT, symptomatic distal DVT, nonfatal PE, and all causes of death. Timepoints:During the study ; Outcome name:A systematic tracking of signs and symptoms will be performed for VTE prior to any diagnostic test for VTE. Measure:The initiation of curative anticoagulant or thrombolytic therapy by the Investigator after evaluation of local VTE. Timepoints:During the study | — |
Countries
Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Italy, Peru, Spain, Sweden
Outcome results
None listed