The subjects who will participate to this clinical trial are patients undergoing Elective Knee Replacement 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 included only if they satisfy the following inclusion criteria: 1. Elective knee replacement surgery or a revision of at least one component of a previously implanted knee prosthesis performed =6 months prior to study entry 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. Any major orthopedic surgery in the 3 months prior to study start 3. Elective knee surgery with polyethylene liner exchange only 4. First step of a two-step exchange arthroplasty for infection after KR 5. Hemostasis prior to the first IP injection not established 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 [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 of the legs (IPC) (only during the study treatment period and until the mandatory venography has been performed) 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 by a Health Care Professional 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 clinical trial of AVE5026 Note: A patient may not be randomized in the study more than onc (i.e randomized more than once). • Exclusion criteria related to enoxaparin 13. Active major bleeding 14. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium 15. Known hypersensitivity to enoxaparin sodium (e.g. pruritus, urticaria, anaphylactoid reactions) 16. Known hypersensitivity to heparin or pork products 17. 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 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 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 Note: 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 Severe Renal Insufficiency patients) with b.i.d. s.c. injections of 30 mg enoxaparin (20 mg q.d. in Severe Renal Insufficiency patients) administered during 7-10 days after surgery for the prevention of venous thromboembolic events (VTE) in patients undergoing elective knee replacement surgery.;Secondary Objective: The secondary objectives of this study are to evaluate the safety of AVE5026 in patients undergoing elective knee replacement 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 randomization up to the day of the mandatory bilateral venography or up to Day 11, whichever comes first. | — |
Countries
Denmark, Estonia, Greece, Lithuania
Outcome results
None listed