Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose Response Study of Subcutaneous AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee replacement [TKR] surgery.

Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.

The randomization had to take place before the first study drug injection.

The total duration of observation per participant was 27-33 days from surgery broken down as follows:

• 4 to 10-day double-blind treatment period;
• Follow-up period up to Day 30 ± 3 after surgery.

Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery.

Inclusion Criteria:

• Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed ≥ 6 months prior to study entry.

Exclusion Criteria:

• Any major orthopedic surgery in the 3 months prior to study entry;
• 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;
• Recent stroke or myocardial infarction;
• High risk of bleeding;
• Treatment with other anti-thrombotic agents within 7 days prior to surgery;
• Any contra-indication to Unfractionated Heparin or Low Molecular Weight Heparin;
• Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.