Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Condition(s) targeted: Venous Thromboembolism

Intervention: AVE5026 (Drug); Enoxaparin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Ajay Kakkar, Prof., MD, PhD, Principal Investigator, Affiliation: Queen Mary's School of Medicine & Dentistry, London (UK)
Alexander Turpie, MD, Study Chair, Affiliation: HHS-General Hospital, Hamilton, Canada

Overall contact:
Public Registry ICD, Email: GV-Contact-us@sanofi-aventis.com

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.

Official title: A 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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Composite of any VTE and death from any cause

Secondary outcome:

Efficacy: Individual Components of the primary outcome measure

Safety: Transfusions, bleeding events, laboratory data, adverse events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Public Registry ICD, Email: GV-Contact-us@sanofi-aventis.com

Sanofi-aventis Administrative Office, Buenos Aires, Argentina; Recruiting

Sanofi-aventis Administrative Office, Wien, Austria; Recruiting

Sanofi-aventis Administraive Office, Minsk, Belarus; Recruiting

Sanofi-aventis Administrative Office, Diegem, Belgium; Recruiting

Sanofi-aventis Administrative Office, Sao Paulo, Brazil; Recruiting

Sanofi-aventis Administrative Office, Sofia, Bulgaria; Recruiting

Sanofi-aventis Administrative Office, Laval, Canada; Recruiting

Sanofi-aventis Administrative Office, Santiago, Chile; Recruiting

Sanofi-aventis Administrative Office, Shangaï, China; Recruiting

Sanofi-aventis Administrative Office, Zagreb, Croatia; Recruiting

Sanofi-aventis Administrative Office, Praha, Czech Republic; Recruiting

Sanofi-aventis Administrative Office, Horsholm, Denmark; Recruiting

Sanofi-aventis Administrative Office, Tallinn, Estonia; Recruiting

Sanofi-aventis Administrative Office, Berlin, Germany; Recruiting

Sanofi-aventis Administrative Office, Budapest, Hungary; Recruiting

Sanofi-aventis Administrative Office, Mumbai, India; Recruiting

Sanofi-aventis Administrative Office, Milano, Italy; Recruiting

Sanofi-aventis Admnistrative Office, Seoul, Korea, Republic of; Recruiting

Sanofi-aventis Administrative Office, Riga, Latvia; Recruiting

Sanofi-aventis Administrative Office, Vilnius, Lithuania; Recruiting

Sanofi-aventis Administrative Office, Mexico, Mexico; Recruiting

Sanofi-aventis Administrative Office, Lysaker, Norway; Recruiting

Sanofi-aventis Administrative Office, Lima, Peru; Recruiting

Sanofi-aventis Administrative Office, Warszawa, Poland; Recruiting

Sanofi-aventis Administrative Office, Bucuresti, Romania; Recruiting

Sanofi-aventis Administrative Office, Moscow, Russian Federation; Recruiting

Sanofi-aventis Administrative Office, Belgrade, Serbia; Recruiting

Sanofi-aventis Administrative Office, Ljubljana, Slovenia; Recruiting

Sanofi-aventis Administrative Office, Midrand, South Africa; Recruiting

Sanofi-aventis Administrative Office, Barcelona, Spain; Recruiting

Sanofi-aventis Administrative Office, Bromma, Sweden; Recruiting

Sanofi-aventis Administrative Office, Kiev, Ukraine; Recruiting

Sanofi-aventis Administrative Office, Guildford Surrey, United Kingdom; Recruiting

Sanofi-aventis Administrative Office, Bridgewater, New Jersey 08807, United States; Recruiting

sanofi-aventis Australia & New Zealand administrative office, Macquarie Park, New South Wales, Australia; Recruiting

Starting date: May 2008
Ending date: July 2010
Last updated: October 16, 2009