Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery (SAVE-HIP2)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00721760

EFC10343

2007-007945-11 (EudraCT Number)

Details and patient eligibility

About

The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing hip fracture surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.

Full description

Randomization had to take place just prior to 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 between 7 to 11 days after surgery.

Enrollment: 1,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Standard surgery for fracture of the upper third of the femur including femoral head and neck.

Exclusion criteria

• 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 post-phlebitic syndrome;
• High risk of bleeding;
• Known 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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1,003 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 Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind

Treatment:

Drug: Placebo

Drug: Semuloparin sodium

Enoxaparin

Active Comparator group

Description:

Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind

Treatment:

Drug: Placebo

Drug: Enoxaparin sodium