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 - TREK

• Conditions: Patients undergoing elective total knee replacement surgery (risk of venous thromboembolic event); MedDRA version: 8.1Level: LLTClassification code 10049909

• Registration Number: EUCTR2005-006202-26-SE
• Lead Sponsor: Sanofi-Aventis Recherche et Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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

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 < 30 ml/min according to Cockroft and Gault formula
- Known progressive malignant disease
- Treatment with any investigational product or investigational device in the last 30 days prior to randomization

Relative to the reference calibrator:
- Uncontrolled arterial hypertension (systolic blood pressure > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified