Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery (SAVE-KNEE)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Semuloparin sodium; Drug: Enoxaparin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718224

2007-007946-37 (EudraCT Number)

EFC10571

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,150 participants in 2 patient groups

Semuloparin

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Semuloparin sodium

Enoxaparin

Active Comparator group

Description:

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

Treatment:

Drug: Enoxaparin

Drug: Placebo