Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

Sanofi469 enrolled

Overview

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery. The secondary objective is to evaluate the safety of extended AVE5026 administration.

The total duration of observation per participant is 56-63 days from surgery broken down as follows: * 7 to 10-day initial treatment period with open-label Semuloparin sodium; * Randomization; * 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo; * 30-day follow-up period. Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

469

Conditions

Venous Thromboembolism

Interventions

Open-label Semuloparin sodiumDRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily with an initial dose given 8 hours after surgery

Placebo (for Semuloparin sodium)DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection once daily

Semuloparin sodiumDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * In the run-in phase: * Standard surgery for fracture of the upper third of the femur, including femoral head and neck * In the double-blind phase following the run-in phase: * Completion of the run-in phase without permanent treatment discontinuation Exclusion Criteria: * Any major orthopedic surgery within 3 months prior to enrolment; * Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome; * High risk of bleeding; * Known hypersensitivity to heparins; * Any contraindication to the performance of venography; * 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 (16)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Minsk, Belarus

Sanofi-Aventis Administrative Office

Outcomes

Primary Outcomes

Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period

VTE include any Deep Vein Thrombosis (DVT) (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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.

Time frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first

Secondary Outcomes

Percentage of Participants Who Experience "Major" VTE or Death From Any Cause

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

Time frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first

Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period

Bleedings are 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 health care professional); "Non-clinically relevant bleeding".

Time frame: From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection

Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period

Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment is 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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