Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery (SAVE-ABDO)


Tracking Information

Start Date  ICMJEMay 2008
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: September 19, 2008)		Composite of any VTE and death from any cause [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: May 16, 2008)		Composite of any VTE and death from any cause [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ]
Change HistoryComplete list of historical versions of study NCT00679588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 19, 2008)
  • Efficacy: Individual Components of the primary outcome measure [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ] [ Designated as safety issue: No ]
  • Safety: Transfusions, bleeding events, laboratory data, adverse events [ Time Frame: Study period ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: May 16, 2008)
  • Efficacy: Individual Components of the primary outcome measure [ Time Frame: From randomization up to the day of the event or the day of the mandatory venography; whichever comes first ]
  • Safety: Transfusions, bleeding events, laboratory data, adverse events [ Time Frame: Study period ]

Descriptive Information

Brief Title  ICMJEEvaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Official Title  ICMJEA 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
Brief Summary

The primary objective of the study is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with q.d. s.c. injections of enoxaparin after surgery for the prevention of venous thromboembolic events in patients undergoing major abdominal surgery.

The secondary objectives of this study are to evaluate the safety of AVE5026 and to document AVE5026 exposures in this population.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEVenous Thromboembolism
Intervention  ICMJE
  • Drug: AVE5026
    once daily subcutaneous injection for 7 to 10 days after surgery
  • Drug: Enoxaparin
    once daily subcutaneous injection for 7 to 10 days after surgery
Study Arms / Comparison Groups
  • 1: Experimental
    Intervention: Drug: AVE5026
  • 2: Active Comparator
    Intervention: Drug: Enoxaparin

Recruitment Information

Estimated Enrollment  ICMJE4400
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing major surgery of the abdomen and/or the pelvis

  • Patients <60 years must have one of the following additional risk factors:

    • History of venous thrombo embolism
    • 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 deep vein thrombosis or pulmonary embolism within the last 12 months or known post phlebitic syndrome
  • Any contra-indications to the performance of venography
  • Patients at high risk of bleeding
  • Known hypersensitivity to heparin or enoxaparin sodium

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

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Registry ICDGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belarus,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Croatia,   Czech Republic,   Denmark,   Estonia,   Germany,   Hungary,   India,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Norway,   Peru,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00679588
Responsible PartyICD Study Director, Sanofi-aventis
Study ID Numbers  ICMJEEFC6520, EudraCT 2007-007942-36
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Ajay Kakkar, Prof., MD, PhDQueen Mary's School of Medicine & Dentistry, London (UK)
Study Chair:Alexander Turpie, MDHHS-General Hospital, Hamilton, Canada
Information Provided BySanofi-Aventis