Design and objectives of the Evaluation of Oral Xemilofiban in ControllingThrombotic Events (EXCITE) study

Clinical trials have demonstrated the efficacy of glycoprotein (GP) IIb/III a antagonists in preventing the thrombotic end points of death, myocardial infarction, and urgent revascularization when they are administered at the lime of percutaneous coronary revascularization (PTCR). It has been postula ted that prolongation of receptor blockade beyond acute intervention would extend the clinical benefit of these agents. The Evaluation of Oral Xemilof iban in Controlling Thrombotic Events (EXCITE) study was a multicenter, int ernational, randomized placebo-controlled trial of the oral GP IIb/IIIa ant agonist xemilofiban administered prior to and after PTCR. The study was des igned to assess the efficacy and safety of continuing oral xemilofiban for 6 months to prevent these primary thrombotic end points. More than 7,200 pa tients were randomized in 29 countries to receive placebo or one of two dos es of xemilofiban. Stenting was performed at the discretion of the operator . All patients received aspirin and periprocedural heparin; all stented pat ients received continuous xemilofiban, or ticlopidine for 2-4 weeks followe d by xemilofiban-placebo. Most patients were also evaluated I month after c onclusion of the study drug treatment. Clinical data from up to 6 months of drug treatment and I month posttreatment were used to evaluate the acute a nd long-term efficacy and safety of xemilofiban. Secondary end points inclu ded the need for any revascularization, repeat hospitalization for unstable angina, and nonhemorrhagic stroke. The cumulative incidence of bleeding ev ents and effects of xemilofiban in stented and nonstented patients were eva luated. The efficacy of continuing xemilofiban and aspirin therapy as the s ole antithrombotic medications following stent deployment was assessed agai nst a ticlopidine and aspirin control group. The incremental clinical benef it of longterm receptor blockade over acute receptor antagonism was evaluat ed.