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

Primary Purpose

Venous Thromboembolism

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semuloparin sodium
Enoxaparin sodium
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous thrombosis, Primary prevention

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • sanofi-aventis Australia & New Zealand administrative office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Semuloparin

Enoxaparin

Arm Description

Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days

Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
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.

Secondary Outcome Measures

Percentage of Participants Who Experienced asymptomatic proximal DVT
Percentage of Participants Who Experienced Clinically Relevant Bleedings
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".
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 CUS.

Full Information

First Posted
July 9, 2008
Last Updated
January 14, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00714597
Brief Title
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
Acronym
SAVE-VEMED
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Venous thrombosis, Primary prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semuloparin
Arm Type
Experimental
Arm Description
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
Intervention Type
Drug
Intervention Name(s)
Semuloparin sodium
Other Intervention Name(s)
AVE5026
Intervention Description
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Enoxaparin sodium
Other Intervention Name(s)
Lovenox®
Intervention Description
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
Description
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.
Time Frame
From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
Secondary Outcome Measure Information:
Title
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.
Title
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Description
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".
Time Frame
From 1st study drug injection up to 3 days after last study drug injection
Title
Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment
Description
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.
Time Frame
From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Mismetti, MD
Organizational Affiliation
University Hospital of Saint-Etienne, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Turpie, MD
Organizational Affiliation
HHS-General Hospital, Hamilton, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
sanofi-aventis Australia & New Zealand administrative office
City
Macquarie Park
State/Province
New South Wales
Country
Australia
Facility Name
Sanofi-Aventis Administrative Office
City
Wien
Country
Austria
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Praha
Country
Czech Republic
Facility Name
Sanofi-Aventis Administrative Office
City
Tallinn
Country
Estonia
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-Aventis Administrative Office
City
Riga
Country
Latvia
Facility Name
Sanofi-Aventis Administrative Office
City
Vilnius
Country
Lithuania
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Auckland
Country
New Zealand
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain
Facility Name
Sanofi-Aventis Administrative Office
City
Kiev
Country
Ukraine
Facility Name
Sanofi-Aventis Administrative Office
City
Guildford Surrey
Country
United Kingdom

12. IPD Sharing Statement

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Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

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