Skip to main content
OpenTrials
Completed

NCT Number: NCT00709904

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Minsk, Belarus

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open-label Semuloparin sodium

Drug

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

Other names: AVE5026

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 sodium

Drug

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

Subcutaneous injection once daily

Other names: AVE5026

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

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

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

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

    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".

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

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

    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.

Other outcomes

  1. Overview of Reported Bleeding Adverse Event

    Time frame: From 1st study drug injection up to 3 days after last study drug injection

    Analysis periods are defined as follows:

    • Initial treatment: time from the first study drug injection up to the first injection in the extension period or up to 3 days after the last injection if no extension treatment;
    • Extension treatment: time from first injection in the extension period up to 3 days after the last injection.

  2. Overview of Deaths

    Time frame: From 1st study drug injection up to 3 days after last study drug injection

    The same analysis periods as defined for the previous outcome measure are used. In addition deaths during the extension treatment period are centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report).

  3. Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)

    Time frame: From 1st study drug injection up to 3 days after last study drug injection

    PCSA are abnormal values considered medically important by the Sponsor according to pre-defined criteria based on literature review. Threshold for platelets count was defined as <100 Giga/L.

    The analysis periods as previously defined are used (see outcome measure 5).

  4. Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)

    Time frame: From 1st study drug injection up to 3 days after last study drug injection

    Thresholds are defined as follows:

    • Alanine Aminotransferase [ALT] >3 Upper Normal Limit [ULN];
    • Total Bilirubin [TB] >2 ULN;
    • ALT >3 ULN and TB >2 ULN;

    Cases with ALT >3 ULN and TB >2 ULN (not necessarily concomitant) are evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria.

    The analysis periods as previously defined are used (see outcome measure 5).

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

Acronym: SAVE-HIP3

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 3, 2008
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.