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Clinical Trials, Vol. 2, No. 3, 233-243 (2005)
DOI: 10.1191/1740774505cn086oa
© 2005 The Society for Clinical Trials

Equipoise in the Enhanced Supression of the Platelet IIb/IIIa Receptor with Integrilin Trial (ESPRIT): a critical appraisal

Howard Mann

Departments of Radiology and Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; Department of Radiology, 1A71 University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA howard.mann{at}hsc.utah.edu

Alex John London

Department of Philosophy and Center for the Advancement of Applied Ethics, Carnegie Mellon University, Pittsburgh, Pennsylvania,

Jeffrey Mann

Salt Lake City, Utah

Enhanced Supression of the Platelet IIb/IIIa Receptor with Integrilin Trial (ESPRIT) was a multicenter randomized controlled clinical trial in which participants were randomized between eptifibatide and placebo. A "clinical hold" was initially placed on the trial by the US Food and Drug Administration (FDA), which was concerned about the placebo-only control arm. The hold was lifted after additional information concerning the use of platelet glycoprotein IIb/IIIa inhibitors in clinical practice, derived from a survey of interventional cardiologists, was provided. The trial's principal investigator and colleagues have described how these issues were resolved, and advance a claim of equipoise for the trial. In this critical appraisal we examine the information and arguments proffered in support of the trial design and conclude that they evidence a misunderstanding of equipoise. We believe that a placebo-only control arm was not justified by the information provided by the trialists.


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