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Completed

NCT Number: NCT00679588

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

The primary objective is to compare the efficacy and safety 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 major abdominal surgery.

The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.

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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

Investigational Site Number 032001, Buenos Aires, Argentina

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About this study

Randomization has to take place prior to the surgery.

The total duration of observation per participant is 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 has to be performed between 7 to 11 days after surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
  • Patient <60 years of age had to have one of the following additional risk factors for VTE:
  • History of VTE,
  • Obesity,
  • Chronic Heart failure,
  • Chronic Respiratory Failure,
  • Inflammatory Bowel Disease,
  • Cancer Surgery.

Exclusion criteria

  • Any major orthopedic or general surgery in the 3 months prior to study start;
  • Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
  • Any contra-indications to the performance of venography;
  • High risk of bleeding;
  • Known hypersensitivity to heparin or Enoxaparin sodium;
  • End stage renal disease or patient on dialysis.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Semuloparin sodium

Drug

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

Subcutaneous injection

Other names: AVE5026

Enoxaparin sodium

Drug

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

Subcutaneous injection

Other names: Lovenox®

Placebo

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

Primary outcomes

  1. Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death

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

    VTE includes any proximal or distal 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 VTE.

    All-cause deaths includes fatal PE and deaths for other reason than PE.

Secondary outcomes

  1. Percentage of Participants Who Experience "major" VTE or All-cause Death

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

    "major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.

  2. Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )

    Time frame: From 1st study drug injection 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);
    • "Nonclinically relevant bleeding".

  3. Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment

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

    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.

Other outcomes

  1. Number of Deaths on Treatment

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

    All deaths 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).

  2. 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 predefined criteria based on literature review.

    Thresholds for platelet counts are defined as <100 Giga/L.

  3. 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.

  4. Trough Plasma Concentration of Semuloparin Sodium (AVE5026)

    Time frame: 0.5-1 and 2-4 hours after Day 1 first post-operative injection, 6-8 and 10-16 hours after Day 4 injection, and just before the last injection

    Trough Plasma Concentration [Ctrough] is defined as plasma concentrations obtained just before study drug injection (i.e.24h±2h after study drug injection).

    Lower Limit Of Quantification (LLOQ) is defined as 0,348 μgEq/mL. Concentrations below LLOQ are replaced by half of LLOQ for the calculation.

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 Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Acronym: SAVE-ABDO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 19, 2008
Registry last updated
Dec 16, 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.

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