The primary objective of the study is to compare the efficacy of AVE5026 with Enoxaparin for
the prevention of Venous Thromboembolic Events (VTE) in patients undergoing elective knee
The secondary objectives of this study are to evaluate the safety of AVE5026 in patients
undergoing elective knee replacement surgery, and to document AVE5026 exposure in this
The total duration of observation per patient is 35 - 42 days from surgery, and includes:
- a treatment period of 7 - 10 days,
- a follow-up period of 28 - 35 days.
Mandatory bilateral venography is performed 7 to 11 days after surgery.
- Knee replacement surgery or revision of at least one component of a knee prosthesis
implanted ≥ 6 months prior to study entry.
- Any major orthopedic surgeries in the 3 months prior to study.
- Deep vein thrombosis or pulmonary embolism within the last 12 months, or known
- Any contraindications to the performance of venography.
- Patients at high risk of bleeding.
- Know allergy to heparin, or enoxaparin, or pork products.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Michael R. LASSEN, MD
Horsholm Hospital, Horsholm, Denmark