Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

Sanofi1,003 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,003

Conditions

Venous Thromboembolism

Interventions

Enoxaparin sodiumDRUG

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

Semuloparin sodiumDRUG

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

PlaceboDRUG

0.4 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or All-cause Death

VTE included any Deep Vein Thrombosis \[DVT\] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.

Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first

Secondary Outcomes

Percentage of Participants Who Experienced "Major" VTE or All-cause Death

"major" VTE included any proximal DVT, symptomatic distal DVT and non-fatal PE as confirmed by the CIAC.

Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first

Percentage of Participants Who Experienced Clinically Relevant Bleedings

Bleedings were centrally and blindly reviewed by the CIAC and classified as: * "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation); * "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by healthcare professional); * "Non-clinically relevant bleeding".

Time frame: From first study drug injection up to 3 days after last study drug injection

Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment

Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory venography.

Data from ClinicalTrials.gov

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