Trial | NCT00718224  Report issue

Title

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
A Multinational, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of Semuloparin (AVE5026) With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1150
The primary objective was to compare the efficacy of Semuloparin sodium (AVE5026) with Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective knee replacement surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.
Randomization had to take place just prior the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 35-42 days from surgery broken down as follows:

7 to 10-day double-blind treatment period;
28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.
Study Started
Jul 31
2008
Primary Completion
May 31
2009
Study Completion
May 31
2009
Last Update
Jan 23
2013
Estimate

Drug Semuloparin sodium

0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe Subcutaneous injection

  • Other names: AVE5026

Drug Enoxaparin

0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe Subcutaneous injection

  • Other names: Lovenox®

Drug Placebo

0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection

Semuloparin Experimental

Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery To maintain the blind, placebo for Enoxaparin sodium: 12 and 24 hours after surgery, then once daily if no SRI 12 hours after surgery only if SRI

Enoxaparin Active Comparator

Enoxaparin sodium 30 mg twice daily (20 mg once daily if Severe Renal Impairment [SRI]) for 7-10 days with an initial dose given 12 hours after surgery Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind

Criteria 

Inclusion Criteria:

- Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry.

Exclusion Criteria:

Any major orthopedic surgeries in the 3 months prior to study;
Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
Any contraindications to the performance of venography;
High risk of bleeding;
Know allergy to heparin, or enoxaparin, or pork products;
End stage renal disease or patient on dialysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
No Results Posted