Patients undergoing elective total knee replacement surgery (risk of venous thromboembolic event) MedDRA version: 8.1 Level: LLT Classification code 10049909
Conditions
Sponsors
Sanofi-Aventis Recherche et Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients planned to undergo elective TKR or a revision of a primary procedure performed = 6 months prior to study entry - Men or women =18 years - 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: Related to study methodology: - Any major orthopedic surgery in the 3 months prior to study start - Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome - Known sensitivity to iodine or contrast dyes - Estimated creatinine clearance 180 mm Hg or diastolic blood pressure > 110 mm Hg) - Ischemic stroke in the last 3 months or any history of hemorrhagic stroke - Myocardial infarction (MI) in the last 3 months - Active or recent (<3 months) significant bleeding, including gastrointestinal bleeding or peptic ulcer - History of bleeding disorder (congenital, acquired or unexplained repeated bleeding episodes) - Known structural damage or other pathologic process involving the central nervous system - Recent (< 3 month) trauma, major surgery or ophthalmic surgery or parenchymal organ biopsy - Treatment with other anti-thrombotic agents within 7 days prior to surgery - Thrombocytopenia (platelet count = 100 x 109/l) - Significant anemia (Hb < 10 g/dl) - History of heparin-induced thrombocytopenia - Any contra-indication to UFH or LMWH Relative to AVE5026: - Pregnant or nursing woman, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To evaluate the safety (incidence of major bleeding) of AVE5026 in the prevention of VTE after elective TKR surgery - To document the efficacy and safety of AVE5026 postoperative regimen in the prevention of VTE after elective TKR surgery - To assess the pharmacokinetic parameters of AVE5026;Main Objective: To demonstrate the efficacy of AVE5026 for primary prophylaxis of Venous Thromboembolism (VTE) via demonstration of a dose-response in patients undergoing elective Total Knee Replacement (TKR) surgery and consequently to identify an appropriate dose for evaluation in other VTE prophylaxis patient populations;Primary end point(s): Composite endpoint of the following VTE outcome results: - Any Deep Vein Thrombosis events (DVT) identified on mandatory venography of the lower limbs - Symptomatic documented DVT and/or non-fatal Pulmonary Embolism (PE) before the mandatory examination - VTE related deaths (fatal PE and deaths which cannot be attributed to a documented cause and for which DVT/PE cannot be ruled out) recorded up to Day 11 or up to the day of mandatory venography [Day 5-Day 11] (whichever comes first), and confirmed by judgment of a blinded Event Adjudication Committee. | — |
Countries
Finland, Greece, Norway, Portugal, Sweden
Outcome results
None listed