Design and Objectives of the Evaluation of Oral Xemilofiban in Controlling Thrombotic Events (EXCITE) Study |
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| Authors: | WILLIAM W. O'NEILL,M.D.,,PATRICK SERRUYS,M.D.,Ph.D.,MERRILL KNUDTSON,M.D.,&dagger ,GERRIT-ANN VAN,ES,M.D.&Dagger ,GERALD C. TIMMIS,M.D.,§ ,COEN VAN DER,ZWAAN,M.D.&# ,JAY KLEIMAN,M.D.,M.P.A.,¶ ,KERRY BARKER,Ph.D.,¶ ,ROGER DREILING,M.D.,#,RICHARD HUBBARD,M.D.,¶ ,JOHN ALEXANDER,M.D.,M.P.H.,¶ ROBERT ANDERS,PHARM.D.,¶ |
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| Affiliation: | William Beaumont Hospital, Royal Oak, Michigan;Cardialysis, Rotterdam, The Netherlands;Foothills Hospital Calgary, Alberta, Canada;William Beaumont Hospital, Royal Oak, Michigan;Thoraxcenter, Rotterdam, The Netherlands;G.D. Searle &Co., Skokie, Illinois;Corvallis Clinic, Corvallis, Oregon |
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| Abstract: | Clinical trials have demonstrated the efficacy of glycoprotein (GP) IIb/IIIa antagonists in preventing the thrombotic end points of death, myocardial infarction, and urgent revascularization when they are administered at the time of percutaneous coronary revascularization (PTCR). It has been postulated that prolongation of receptor blockade beyond acute intervention would extend the clinical benefit of these agents. The Evaluation of Oral Xemilofiban in Controlling Thrombotic Events (EXCITE) study was a multicenter, international, randomized placebo-controlled trial of the oral GP IIb/IIIa antagonist Xemilofiban administered prior to and after PTCR. The study was designed to assess the efficacy and safety of continuing oral xemilofiban for 6 months to prevent these primary thrombotic end points. More than 7,200 patients were randomized in 29 countries to receive placebo or one of two doses of xemilofiban. Stenting was performed at the discretion of the operator. All patients received aspirin and periprocedural heparin; all stented patients received continuous xemilofiban, or ticlopidine for 2–4 weeks followed by xemilofiban-placebo. Most patients were also evaluated 1 month after conclusion of the study drug treatment. Clinical data from up to 6 months of drug treatment and 1 month posttreatment were used to evaluate the acute and long-term efficacy and safety of xemilofiban. Secondary end points included the need for any revascularization, repeat hospitalization for unstable angina, and nonhemorrhagic stroke. The cumulative incidence of bleeding events and effects of xemilofiban in stented and nonstented patients were evaluated. The efficacy of continuing xemilofiban and aspirin therapy as the sole antithrombotic medications following stent deployment was assessed against a ticlopidine and aspirin control group. The incremental clinical benefit of long-term receptor blockade over acute receptor antagonism was evaluated. |
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