The subjects who will participate to this clinical trial are patients undergoing Hip Fracture Surgery. MedDRA version: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Interventions
Product Code: AVE5026
Pharmaceutical Form: Solution for injection
Current Sponsor code: AVE5026
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical f
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients can be included only if they satisfy the following inclusion criteria: 1. Standard surgery for fracture of the upper third of the femur, including femoral head and neck. 2. Signed written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria related to study methodology: 1. Legal lower age limitations (country specific) 2. Estimated time of injury/fracture >24 hours before admission to hospital 3. Time from injury/fracture to surgery >60 hours 4. Any major orthopedic surgery in the 3 months prior to study start 5.multiple trauma affecting more than one organ system 6. Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome 7. Known sensitivity to iodine or contrast dyes and any contra-indications to the performance of venography 8. Any treatment or procedure 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: - Parenteral anticoagulants (UFH, LMWH [i.e. enoxaparin, dalteparin, nadroparin,...], fondaparinux, bivalirudin, hirudin) - Oral anticoagulants (e.g. vitamin K antagonists...) - GPIIb/IIIa antagonists: abciximab, eptifibatide, tirofiban - Thrombolytic agents - Dextrans - Intermittent pneumatic compression of the legs (IPC) Note: Chronic treatment with antiplatelet agents such as low-dose aspirin (up to 325 mg/day), clopidogrel or ticlopidine in patients with coronary artery disease is allowed 9. Known progressive malignant disease 10. Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, inability to receive daily injection (preferably by a nurse) after hospital discharge and unlikelihood of completing the study 11. Treatment with any investigational product or investigational device in the last 30 days or 5 half lives (whichever is longer, if relevant) prior to randomization 12. any previous exposure to AVE5026 (e.g participation in any previous AVE5026 clinical trial) Exclusion criteria related to enoxaparin: 12. Active major bleeding 13. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium 14. Known hypersensitivity to enoxaparin sodium (e.g. pruritus, urticaria, anaphylactoid reactions) 15. Known hypersensitivity to heparin or pork products 16. 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 ophtalmological surgery Exclusion criteria related to AVE5026: 17. End stage renal disease (creatinine clearance <10 mL/min) or patient on dialysis 18. Pregnant or breast-feeding women 19. Women of childbearing potential not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form and/or who are unwilling or unable to be tested for pregnancy. Pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy of once daily (q.d.) subcutaneous (s.c.) injections of 20 mg AVE5026 (10 mg in patients with severe renal insufficiency [SRI]) with q.d. s.c. injections of 40 mg enoxaparin (20 mg in patients with SRI) administered during 7-10 days after surgery for the prevention of venous thromboembolic events (VTE), i.e. deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients undergoing hip fracture surgery. ;Secondary Objective: The secondary objectives of this study are to evaluate the safety of AVE5026 in patients undergoing elective hip fracture surgery, and to document AVE5026 exposures in this population. ;Primary end point(s): The primary efficacy endpoint is a composite of any VTE confirmed by a blinded Central Independent Adjudication Committee (CIAC), and deaths from any cause reported during the efficacy evaluation period. The efficacy evaluation period lasts from the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first. Mandatory bilateral venography of the lower limbs should be performed within one calendar day of last dosing. The results of the mandatory bilateral venography will be adjudicated by the CIAC, and only the results of the adjudication will be considered. -Clinical diagnosis DVT of the lower limbs must be confirmed by compression ultrasound or venography -Clinical diagnosis of PE must be confirmed by ventilation/perfusion lung scan, pulmonary angiogram or spiral Computer Tomography (CT) lung scan Whenever an Investigator requests diagnostic tests for VTE, these tests will be performed, an adjudication package will be prepared, and sent to the CIAC (see specific operational manual). Prior to any diagnostic test for VTE, a systematic assessment of signs and symptoms of VTE will be performed. Note: all deaths will be adjudicated by the CIAC to be classified as VTE-related death, fatal bleeding or other | — |
Countries
Bulgaria, Czech Republic, Denmark, Finland, Greece, Italy, Portugal, Spain, Sweden
Outcome results
None listed