Trial Design

DOI: 10.4244/EIJ-D-24-00203

Cangrelor versus crushed ticagrelor in patients with acute myocardial infarction and cardiogenic shock: rationale and design of the randomised, double-blind DAPT-SHOCK-AMI trial

Zuzana Motovska1, MD, PhD; Ota Hlinomaz2,3, MD, CSc; Jan Mrozek4, MD, PhD; Petr Kala5, MD, PhD; Tobias Geisler6, MD, MHBA; Milan Hromadka7, MD, PhD; Ibrahim Akin8, MD, PhD; Jan Precek9, MD, PhD; Jiri Kettner10, MD, CSc; Pavel Cervinka11,12, MD, PhD; Gilles Montalescot13, MD, PhD; Jiri Jarkovsky14, MSc, PhD; Jan Belohlavek15, MD, PhD; Josef Bis12, MD, PhD; Jan Matejka16, MD, PhD; Alexandra Vodzinska17, MD; Tamilla Muzafarova1, MD; Pavol Tomasov18, MD, PhD; Alexander Schee19, MD, MBA; Stanislav Bartus20, MD; Andrea Andrasova21, MD; Christoph B. Olivier22, MD; Ales Kovarik23, MD; Petr Ostadal24,25, MD, PhD; Regina Demlova26, MD, PhD; Lenka Souckova26, PharmD, PhD; Ivan Vulev3, MD, PhD, MPH; Zdeněk Coufal27, MD; Janusz Kochman28, MD, PhD; Iuri Marinov29, MD, CSc; Jacek Kubica30, MD, PhD; Gregory Ducrocq31, MD, PhD; Michal Karpisek32, MEng; Zdenek Klimsa33, MD; Martin Hudec34, MD; Petr Widimsky1, MD, DrSc; Deepak L. Bhatt35, MD, MPH, MBA; DAPT-SHOCKAMI study group

Abstract

Cardiogenic shock (CS) is a devastating and fatal complication of acute myocardial infarction (AMI). CS can affect the pharmacokinetics and pharmacodynamics of medications. The unique properties of cangrelor make it the optimal P2Y12 inhibitor for CS-AMI, in terms of both efficacy and safety. The DAPT-SHOCK-AMI trial (ClinicalTrials.gov: NCT03551964; EudraCT: 2018-002161-19) will assess the benefits of cangrelor in patients with an initial CS-AMI undergoing primary angioplasty. This randomised, multicentre, placebo-controlled trial of approximately 550 patients (with an allowed 10% increase) in 5 countries using a double-blind design will compare initial P2Y12 inhibitor treatment strategies in patients with CS-AMI of (A) intravenous cangrelor and (B) ticagrelor administered as crushed tablets at a loading dose of 180 mg. The primary clinical endpoint is a composite of all-cause death, myocardial infarction (MI), or stroke within 30 days. The main secondary endpoints are (1) the net clinical endpoint, defined as death, MI, urgent revascularisation of the infarct-related artery, stroke, or major bleeding as defined by the Bleeding Academic Research Consortium criteria; (2) cardiovascular-related death, MI, urgent revascularisation, or heart failure; (3) heart failure;...

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Volume 20 Number 20
Oct 21, 2024
Volume 20 Number 20
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