+1 Recommend
0 collections
      • Record: found
      • Abstract: found
      • Article: not found

      Equipoise in the enhanced supression of the platelet IIb/IIIa receptor with integrilin trial (ESPRIT): a critical appraisal.

      Clinical Trials (London, England)
      Angioplasty, Balloon, Coronary, Attitude of Health Personnel, Clinical Trials Data Monitoring Committees, ethics, Costs and Cost Analysis, Ethics, Research, Humans, Multicenter Studies as Topic, Patient Selection, Peptides, therapeutic use, Physicians, Placebos, Platelet Aggregation Inhibitors, Platelet Glycoprotein GPIIb-IIIa Complex, antagonists & inhibitors, Randomized Controlled Trials as Topic, Research Design, Social Responsibility, Stents, United States, United States Food and Drug Administration

      Read this article at

          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.


          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.

          Related collections

          Author and article information


          Comment on this article