P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial
Patrícia O. Guimarães, Marcelo Franken, Caio A.M. Tavares, Fábio Serra Silveira, Murillo de Oliveira Antunes, Ricardo Reinaldo Bergo, Rodrigo M Joaquim, Jessica C S Hirai, Pedro Beraldo de Andrade, Fábio Grunspun Pitta, José Mariani, Bruno Ramos Nascimento, João Eduardo Tinoco de Paula, Marcos S. Silveira, Tiberio A O Costa, Frederico Toledo Campo Dall’Orto, Renato G Serpa, Fernanda B.A. Sampaio, Louis N Ohe, Fernanda Mangione, Remo H.M. Furtado, Rogério Sarmento‐Leite, Frederico Monfardini, Silvia Regina Lamas Assis, José Carlos Nicolau, Andrei C. Spósito, Renato D. Lópes, Yoshinobu Onuma, Marco Valgimigli, Dominick J. Angiolillo, Patrick W. Serruys, Otávio Berwanger, Fernando Bacal, Pedro A. Lemos
Abstract
inhibitor) for 12 months. Aspirin is discontinued immediately after randomisation in the SAPT group. The choice between ticagrelor and prasugrel is at the investigator's discretion. The primary hypothesis is that SAPT will be non-inferior to DAPT with respect to the composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularisation, but superior to DAPT on rates of bleeding defined by Bleeding Academic Research Consortium 2, 3 or 5 criteria. NEOMINDSET is the first study that is specifically designed to test SAPT versus DAPT immediately following PCI with DES in ACS patients. This trial will provide important insights on the efficacy and safety of withdrawing aspirin in the early phase of ACS. (ClinicalTrials.gov: NCT04360720).