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 hip fracture
The secondary objectives of this study are to evaluate the safety of AVE5026 in patients
undergoing hip fracture surgery, and to document AVE5026 exposure in this population.
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.
- Standard surgery for fracture of the upper third of the femur including femoral head
- Estimated time of injury/fracture > 24 hours before admission to hospital
- Any major orthopedic surgery in the 3 months prior to study start
- Multiple trauma affecting more than one organ system
- Deep vein thrombosis or pulmonary embolism within the last 12 months or known
- Patients at high risk of bleeding
- Known 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.
William D. Fisher, MD
Department of Orthopaedic Surgery, McGill University Health Centre, 1650 Cedar Avenue, Montreal, Que