The subjects who will participate to this clinical trial are patients having undergone hip fracture surgery. MedDRA version: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients can be enrolled in the run-in phase only if they satisfy the following selection criteria for enrollment (ENR): - ENR1. Standard surgery for fracture of the upper third of the femur, including femoral head and neck with incision closure performed 8±1 hours previously, and provided that hemostasis has been established, - ENR2. Signed written informed consent. Patients can be randomized at the end of the run-in phase only if they satisfy the following selection criteria for randomization: - R1. Patients who completed the run-in phase without permanent discontinuation of AVE5026 prevention, - R2. And still complying with the selection criteria of the run-in phase. 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 before hospital admission > 24 hours 3. Time from hospital admission to surgery > 36 hours* * If time from injury to hospital admission is documented to be less than 24 hours, this 36 hours time window can be expanded but in all cases the time from injury to surgery must not exceed 60 hours. 3A1. Multiple trauma affecting more than one organ system 4. Any major orthopedic surgery within 3 months prior to enrollment 5. Hemorrhagic stroke or recent (less than 3 months prior to enrollment) brain, spinal or ophtalmological surgery 6. Active or recent (<3 months) significant bleeding, including gastro-intestinal bleeding 7. Hemostasis prior to the first AVE5026 injection of the run-in phase, not established 8. Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome 9. Known sensitivity to iodine or contrast dyes, and any contraindication to the performance of venography 10. Any treatment within 2 weeks prior to enrollment in the run-in phase or planned during the course of the run-in phase and double-blind treatment phase, that could affect the incidence of VTE such as: •Parenteral anticoagulants (UFH, LMWH [e.g. 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 *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 10A1. Patient with sigificant loss of mobility prior to fracture or with any severe medical conditions requiring a prolonged venous thromboprophylaxis according to the investigator`s judgment 11. Known progressive malignant disease 12. Subject unlikely to comply with protocol (e.g. uncooperative attitude, inability to return for follow-up visits, inability to receive daily injection by a Health Care Professional) after hospital discharge and unlikelihood of completing the study 13. Treatment with any Investigational Product or investigational device in the last 30 days or 5 half lives (whichever is longer, if relevant) prior to enrollment/randomization 14. Any previous exposure to AVE5026 (e.g. participation in any previous AVE5026 clinical trial) *Note: A patient may not be enrolled in the run-in phase or randomized for the double-blind treatment phase of the study more than once 15. Refusal or inability to give informed consent to participate in the study - Exclusion criteria related to AVE5026: 16. History of heparin-induced thrombocytopenia 17. Know hypersensitivity to UFH or LMWH 18. End stage renal disease (estimated creatinine clearance <10 mL/min [see Appendix B]) or patient on dialysis 19. Pregnant or breast-feeding women 20. Women of childbearing potential not protected by 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. *Note: Pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the open-label or investigational product. - Exclusion criteria related to the run-in phase (to be checked before randomization): 21. Occurrence of exclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of once daily (q.d.) subcutaneous (sc) injections of 20 mg AVE5026 (10 mg in patients with severe renal insufficiency [SRI]) with placebo during 3 additional weeks following an initial 7 to 10 days of open-label venous thromboprophylaxis with q.d. sc injections of 20 mg AVE5026 (10 mg in patients with SRI) for the prevention of venous thromboembolic events (VTE), i.e. deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients having undergone hip fracture surgery.;Secondary Objective: To evaluate the safety of extended AVE5026 prevention in patients having undergone hip fracture surgery.;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 randomization up to the day of the mandatory bilateral venography, or up to Day 24, whichever comes first. | — |
Countries
Lithuania
Outcome results
None listed