Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study prot
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STUDY PROTOCOL
Open Access
Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial Giuseppe Tarantini1*†, Marco Mojoli2† , Ferdinando Varbella3, Roberto Caporale4, Stefano Rigattieri5, Giuseppe Andò6, Plinio Cirillo7, Simona Pierini8, Andrea Santarelli9, Paolo Sganzerla10, Nicoletta De Cesare11, Ugo Limbruno12, Alessandro Lupi13, Roberto Ricci14, Carlo Cernetti15, Luca Favero15, Francesco Saia16, Loris Roncon17, Valeria Gasparetto18, Marco Ferlini19, Federico Ronco20, Luca Ferri21, Daniela Trabattoni22, Alessandra Russo23, Vincenzo Guiducci24, Carlo Penzo25, Fabio Tarantino26, Ciro Mauro27, Alfredo Marchese28, Battistina Castiglioni29, Alessio La Manna30, Matteo Martinato1, Dario Gregori1, Dominick J. Angiolillo31 and Giuseppe Musumeci32
Abstract Background: The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors—ticagrelor and prasugrel—currently recommended by the guidelines. Study design: DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. (Continued on next page)
* Correspondence: [email protected] † Giuseppe Tarantini and Marco Mojoli contributed equally to this work as cofirst authors. 1 Department of Cardiac, Thoracic, and Vascular Sciences and Public Health, Policlinico Universitario, University of Padova, Via Giustiniani 2, 35128 Padova, Italy Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Com
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