Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility (SAVE-VEMED)

January 14, 2013 updated by: Sanofi

A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

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 primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomization had to take place just prior to the first study drug injection.

The total duration of observation per participant was 35-42 days from randomization broken down as follows:

  • 10 to 14-day double-blind treatment period;
  • 25 to 32-day follow-up period.

Mandatory bilateral compression ultrasound [CUS] had to be performed between 10 to 15 days after randomization.

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia
        • sanofi-aventis Australia & New Zealand administrative office
  • Austria
      • Wien, Austria
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • Estonia
      • Tallinn, Estonia
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis Administrative Office
  • India
      • Mumbai, India
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Sanofi-Aventis Administrative Office
  • Latvia
      • Riga, Latvia
        • Sanofi-Aventis Administrative Office
  • Lithuania
      • Vilnius, Lithuania
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • New Zealand
      • Auckland, New Zealand
        • Sanofi-Aventis Administrative Office
  • Romania
      • Bucuresti, Romania
        • Sanofi-Aventis Administrative Office
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • Ukraine
      • Kiev, Ukraine
        • Sanofi-Aventis Administrative Office
  • United Kingdom
      • Guildford Surrey, United Kingdom
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:

  • Congestive heart failure (New York Heart Association [NYHA] class III/IV);
  • Acute respiratory failure (not requiring mechanical ventilation);
  • Acute infection (without septic shock)*;
  • Acute rheumatic disorder*;

  • Acute episode of inflammatory bowel disease*.

    • Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:

      • Age ≥ 75 years;
      • Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months);
      • Previous VTE;
      • Obesity;
      • Oral hormone therapy (antiandrogen or estrogen);
      • Chronic heart failure;
      • Chronic respiratory failure.

Exclusion Criteria:

  • Previous surgery with general anesthesia within 30 days before inclusion in the study;
  • Patient requiring a curative anticoagulant or thrombolytic treatment;
  • Patient at risk of bleeding;
  • Stroke;
  • Known hypersensitivity to heparin or enoxaparin sodium;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Semuloparin
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
Drug: Semuloparin sodium

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

Subcutaneous injection

Other Names:
  • AVE5026
ACTIVE_COMPARATOR: Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
Drug: Enoxaparin sodium

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

Subcutaneous injection

Other Names:
  • Lovenox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
Time Frame: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first

VTE included:

  • asymptomatic proximal Deep Vein Thrombosis (DVT) detected by the mandatory CUS and confirmed by a Compression Ultrasound Adjudication Committee (CUSAC) after central and blind review of the mandatory CUS;
  • symptomatic DVT and non-fatal Pulmonary Embolism (PE) reported by the investigator and confirmed by a Central Independent Adjudication Committee (CIAC) after central and blind review of diagnosis tests.

VTE-related Death included fatal PE and unexplained deaths.
From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced asymptomatic proximal DVT
Time Frame: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.
From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Time Frame: From 1st study drug injection up to 3 days after last study drug injection

Bleedings were centrally and blindly reviewed by the CIAC and classified as:

  • "major" (fatal, symptomatic in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood);
  • "clinically relevant non-major" (overt bleeding requiring medical intervention and not meeting criteria for major bleeding);
  • "Non-clinically relevant bleeding".
From 1st 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
Time Frame: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came 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 CUS.
From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Patrick Mismetti, MD, University Hospital of Saint-Etienne, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (ESTIMATE)

July 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC10572
  • 2008-000228-13 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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