Trial design

DOI: 10.4244/EIJ-D-22-01006

A prospective study comparing short versus standard dual antiplatelet therapy in patients with acute myocardial infarction: design and rationale of the TARGET-FIRST trial

Giuseppe Tarantini1, MD, PhD; Peter Cornelius Smits2, MD, PhD; Thibault Lhermusier3, MD, PhD; Benjamin Honton4, MD; Grégoire Rangé5, MD; Christophe Piot6, MD, PhD; Gilles Lemesle7,8,9, MD, PhD; Juan Miguel Ruiz Nodar10, MD, PhD; Matthieu Godin11, MD; Maria Madera Cambero12, MD; Pascal Motreff13, MD, PhD; Thomas Cuisset14, MD, PhD; David Bouchez15, MSc; Yann Poezevara15, MSc; Guillaume Cayla16, MD, PhD

Abstract

Based on the latest knowledge and technological advancements, it is still debatable whether a modern revascularisation approach in the setting of acute myocardial infarction (AMI), including complete revascularisation (in patients with significant non-culprit lesions) with newer-generation highly biocompatible drug-eluting stents, requires prolonged dual antiplatelet therapy (DAPT). TARGET-FIRST (ClinicalTrials.gov: NCT04753749) is a prospective, open-label, multicentre, randomised controlled study comparing short (one month) DAPT versus standard (12 months) DAPT in a population of patients with non-ST/ST-segment elevation myocardial infarction, completely revascularised at index or staged procedure (within 7 days), using Firehawk, an abluminal in-groove biodegradable polymer rapamycin-eluting stent. The study will be conducted at approximately 50 sites in Europe. After a mandatory 30-40 days of DAPT with aspirin and P2Y12 inhibitors (preferably potent P2Y12 inhibitors), patients are randomised (1:1) to 1) immediate discontinuation of DAPT followed by P2Y12 inhibitor monotherapy (experimental arm), or 2) continued DAPT with the same regimen (control arm), up until 12 months. With a final sample size of 2,246 patients, the study is powered to evaluate the primary endpoint (non-inferiority of short antiplatelet therapy in completely revascularised patients) for net adverse clinical and...

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Volume 19 Number 3
Jun 19, 2023
Volume 19 Number 3
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