EFC6204 TAO - Efficacy of Otamixaban in unstable Angina/NSTEMI
Research type
Research Study
Full title
Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with Unfractionated Heparin + eptifibatide, in patients with Unstable angina/Non ST segment Elevation Myocardial Infarction scheduled to undergo an early invasive strategy.
IRAS ID
65523
Contact name
Farqad Alamgir
Sponsor organisation
sanofi-aventis
Eudract number
2009-016568-36
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
The purpose of the study is to evaluate the effectiveness of using Otamixaban compared to Unfractionated Heparin (UFH) and Eptifibatide in patients who have acute coronary syndromes (ACS) with planned early intervention. ACS is a major cause of death and disability worldwide. It is caused by a complex interaction (coagulation process) that results in the formation of a blood clot within the blood vessels supplying the heart. This leads to a decreased blood flow in the arteries supplying the heart limiting the oxygen delivery to the heart. UFH has been the treatment of choice for ACS patients presenting with non-ST elevation acute coronary syndrome in early invasive setting. However, there are various limitations of UFH as its unpredictable action on clotting requires close monitoring of the patient. Otamixaban has a more predictable and a direct action on clotting compared to UFH and has been shown to have better efficacy and safety in the ACS patients in previous phase 2 studies. SEPIA-PCI is a phase 2 study in patients who required a non-urgent PCI. This study compared otamixaban versus UFH and found that clotting was significantly reduced in patients who received the highest dose of otamixiaban compared to UFH. In SEPIA-ACS study, ACS patients undergoing early invasive strategy were studied with five different doses of otamixaban and compared to UFH plus eptifibatide. Although the lowest dose was dropped early as recommended by Data and Safety Monitoring committee, the remaining otamixaban doses demonstrated more favourable results compared to UFH in the primary efficacy endpoint with the intermediate doses showing a better efficacy compared to UFH whilst showing similar rates of bleeding compared to the comparator arm. This trial will study similar patients to the SEPIA-ACS study; it has been designed to confirm the findings from previous studies and help select the right otamixaban dose.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
11/NE/0015
Date of REC Opinion
31 Mar 2011
REC opinion
Further Information Favourable Opinion