Design and rationale of the Treatment of Acute Coronary Syndromes with Otamixaban trial: A double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non–ST-segment elevation acute coronary syndromes with a planned early invasive strategy

BACKGROUND: Otamixaban is a synthetic intravenous direct factor Xa inhibitor, with rapid onset/offset, linear kinetics, and no significant renal elimination. A phase II trial in acute coronary syndromes (ACS) showed a marked reduction in the combined end point of death or myocardial infarction (MI) and similar bleeding rates with otamixaban at midrange doses, compared with unfractionated heparin (UFH) and eptifibatide. DESIGN: The TAO trial is …