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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

July 9, 2008
January 14, 2013
July 2008
March 2009   (final data collection date for primary outcome measure)
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.

Composite of any asymptomatic proximal Deep Vein Thrombosis, any confirmed VTE and any VTE-related deaths (fatal Pulmonary Embolism or unexplained death) [ Time Frame: From randomization up Day 15 or the day of the mandatory Compression Ultrasound (CUS); whichever comes first. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00714597 on ClinicalTrials.gov Archive Site
  • 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.
  • Each component of the primary efficacy endpoint up to Day 15 or up to the day of the mandatory CUS (whichever comes first) [ Time Frame: From randomization up Day 15 or the day of the mandatory CUS; whichever comes first. ] [ Designated as safety issue: No ]
  • Bleeding events, transfusions, laboratory data, adverse events, deaths [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Venous Thromboembolism
  • 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
  • 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®
  • Experimental: Semuloparin
    Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
    Intervention: Drug: Semuloparin sodium
  • Active Comparator: Enoxaparin
    Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days
    Intervention: Drug: Enoxaparin sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
421
March 2009
March 2009   (final data collection date for primary outcome measure)

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.

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   Czech Republic,   Estonia,   France,   Germany,   Hungary,   India,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Romania,   Russian Federation,   Spain,   Ukraine,   United Kingdom
 
NCT00714597
EFC10572, 2008-000228-13
Yes
Sanofi
Sanofi
Not Provided
Principal Investigator: Patrick Mismetti, MD University Hospital of Saint-Etienne, France
Study Chair: Alexander Turpie, MD HHS-General Hospital, Hamilton, Canada
Sanofi
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP