AVE5026 for prevention of VTE in patients undergoing abdominal sugery
Research type
Research Study
Full title
A Multinational, Multicentre, Randomised, Double Blind Study comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
Sponsor organisation
Sanofi Aventis
Eudract number
2007-007942-36
ISRCTN Number
dd
Research summary
Patients undergoing surgery are at a higher risk of venous thromboembolism (VTE), which is the formation of a blood clot in a vein. The clot potentially can leave the vein and enter the lungs, if it gets lodged within the lungs it can cause a pulmonary embolism that may result in death. The study drug has shown promising results in preventing VTEs in a total knee replacement study, and the aim of the development of this drug is to improve the benefit/risk ratio over other currently available blood thinners. The study will involve daily injections, which will be given by trained hospital staff. The study drug is being compared to another drug (this second drug is known as the comparator) which already has marketing approval, to see if it is more or less effective. The study is a double blind study so neither the doctor nor the patient will know which drug they are receiving.The main objective is to compare the effectiveness of a once daily injection of the study drug compared to a comparator for prevention of VTE for patients who are acutely ill and will be requiring bed rest for at least 3 days.Due to the brief duration of the study, most study visits will take place while the patient remains in hospital. These visits will involve various tests to check on their health, safety, and the effect the study drug may be having on them. The study is a worldwide commercially funded study, with several UK sites.
REC name
London - Westminster Research Ethics Committee
REC reference
08/H0802/151
Date of REC Opinion
8 Apr 2009
REC opinion
Further Information Favourable Opinion