Research trial protocolsA multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): trial study design and rationaleSardella, Gennaro; Sangiorgi, Giuseppe M; Mancone, Massimo; Colantonio, Riccardo; Donahue, Michael; Politi, Luigi; Ducci, Chiara B; Carbone, Iacopo; Francone, Marco; Ligabue, Guido; Fiocchi, Federica; Di Roma, Angelo; Benedetti, Giulia; Lucisano, Luigi; Stio, Rocco E; Agati, Luciano; Modena, Maria G; Genuini, Igino; Fedele, Francesco; Gibson, MichaelAuthor Information aDepartment of Cardiovascular and Respiratory Sciences, Policlinico Umberto I, ‘Sapienza’ University of Rome, Italy bDepartment of Cardiology, Policlinico of Modena, University of Modena and Reggio Emilia, Modena, Italy cCMR Unit, Royal Brompton Hospital, Imperial College, NHLI, London, UK dDepartment of Radiology, Policlinico Umberto I, ‘Sapienza’ University of Rome, Italy eDepartment of Radiology, Policlinico of Modena, University of Modena and Reggio Emilia, Modena, Italy fCardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass, USA Received 8 July, 2009 Revised 4 September, 2009 Accepted 12 October, 2009 Correspondence to Gennaro Sardella, MD, FACC, FESC, Department of Cardiovascular Sciences, Policlinico Umberto I, ‘Sapienza’ University of Rome, Rome, Italy Tel: +39 0 649979035; fax: +39 0 649979047; e-mail: [email protected] G. Sardella and G.M. Sangiorgi contributed equally to this paper. Journal of Cardiovascular Medicine: July 2010 - Volume 11 - Issue 7 - p 529-535 doi: 10.2459/JCM.0b013e3283341c1c Buy Erratum Metrics Abstract Background Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction. Adjunctive therapy with platelet glycoprotein (GP) IIb/IIIa inhibitor can result in increased vessel patency and improved outcomes in ST-elevation myocardial infarction patients undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes. Methods IC-Clearly is a randomized, open-label, multicenter trial, with the purpose of evaluating the effectiveness of an intracoronary bolus dose of abciximab delivered using the ClearWay RX catheter vs. an intravenous bolus of abciximab for ST-elevation myocardial infarction with angiographically visible thrombus (thrombus grade ≥2). A total of 150 patients will be randomized 1: 1 to treatment of the culprit artery with intracoronary abciximab (75 patients) or intravenous abciximab (75 patients) in addition to a maintenance infusion regimen of abciximab administered intravenously for 12 h after PCI. The number of patients included in this study is based on the estimation of sample size needed to identify a statistically significant difference in the primary endpoints between the two groups. The primary endpoint chosen to evaluate this hypothesis is infarct size assessed by cardiac magnetic resonance. Clinical outcomes will be assessed for each patient through hospital discharge and at 30-day follow-up. Conclusion The purpose of this study is to evaluate whether an intracoronary bolus of abciximab delivered with the ClearWay RX catheter prior to the 12 h post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo and improved myocardial perfusion when compared with an intravenous bolus of abciximab on top of the 12 h post-PCI intravenous infusion regimen of abciximab as per standard practice. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed by cardiac magnetic resonance. Erratum An author's surname was incorrectly reproduced in this article. Ducci CB should have appeared as Bucciarelli-Ducci C. Journal of Cardiovascular Medicine. 16(4):320, April 2015. © 2010 Italian Federation of Cardiology. All rights reserved.