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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00714597
First received: July 9, 2008
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Drug: Semuloparin sodium
Drug: Enoxaparin sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first. ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experienced Clinically Relevant Bleedings [ Time Frame: From 1st study drug injection up to 3 days after last study drug injection ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first ] [ Designated as safety issue: No ]
    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.


Enrollment: 421
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Lovenox®

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714597

  Show 22 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Patrick Mismetti, MD University Hospital of Saint-Etienne, France
Study Chair: Alexander Turpie, MD HHS-General Hospital, Hamilton, Canada
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00714597     History of Changes
Other Study ID Numbers: EFC10572, 2008-000228-13
Study First Received: July 9, 2008
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Venous thrombosis
Primary prevention

Additional relevant MeSH terms:
Venous Thromboembolism
Venous Thrombosis
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on September 22, 2014