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

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; and (4) cardiovascular-related death, all (1-4) within 1 year after study enrolment. A platelet reactivity study that tests the laboratory antiplatelet benefits of cangrelor, when given in addition to standard antiplatelet therapy, will be conducted using vasodilator-stimulated phosphoprotein phosphorylation. The primary laboratory endpoints are the periprocedural rate of onset and the proportion of patients who achieve effective P2Y12 inhibition. The DAPT-SHOCK-AMI study is the first randomised trial to evaluate the benefits of cangrelor in patients with CS-AMI.

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Journal
EuroIntervention
Published
2024-10-01
DOI
https://doi.org/10.4244/eij-d-24-00203
Citations
7
Primary Topic
Antiplatelet Therapy and Cardiovascular Diseases
Type
article
Field-Weighted Citation Impact
2.81

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article

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

Zdeněk Klimsa, Martin Hudec, Deepak L. Bhatt, Stanisław Bartuś et al.
7 citations
EuroIntervention
Antiplatelet Therapy and Cardiovascular Diseases
2.81
article

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

Zdeněk Klimsa, Martin Hudec, Deepak L. Bhatt, Stanisław Bartuś, Grégory Ducrocq, Pavol Tomašov, Jiří Kettner, Gilles Montalescot, Iuri Marinov, Andrea Andrášová, Zdeněk Coufal, Janusz Kochman, Alexander Schee, Jiří Jarkovský, Lenka Součková, Michal Karpíšek, Jan Mrózek, Petr Kala, İbrahim Akın, Aleš Kovařı́k, Christoph B. Olivier, Milan Hromadka, Pavel Červinka, Jacek Kubica, Zuzana Moťovská, Josef Bis, Alexandra Vodzinská, Tamilla Muzafarova, Jan Přeček, Jan Matějka, Regina Demlová, Ota Hlinomaz, Tobias Geisler, Ivan Vulev, Petr Widimský, Petr Ostadal, Jan Belohlavek, Dapt-Shockami Study Group
article en
7 citations

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; and (4) cardiovascular-related death, all (1-4) within 1 year after study enrolment. A platelet reactivity study that tests the laboratory antiplatelet benefits of cangrelor, when given in addition to standard antiplatelet therapy, will be conducted using vasodilator-stimulated phosphoprotein phosphorylation. The primary laboratory endpoints are the periprocedural rate of onset and the proportion of patients who achieve effective P2Y12 inhibition. The DAPT-SHOCK-AMI study is the first randomised trial to evaluate the benefits of cangrelor in patients with CS-AMI.

EuroInterventionVol. 20(20)
Université Claude Bernard Lyon 1 (FR), Charles University (CZ), Masaryk University (CZ), Heidelberg University (DE), Nicolaus Copernicus University (PL), Hospital Jihlava (CZ), Institute of Haematology and Blood Transfusion (CZ), University Hospital in Motol (CZ), Mount Sinai Hospital (US), University Hospital Brno (CZ), Na Homolce Hospital (CZ), Krajská nemocnice T. Bati (CZ), University Hospital Kralovske Vinohrady (CZ), University Medical Centre Mannheim (DE), Icahn School of Medicine at Mount Sinai (US)
Univerzita Karlova v Praze, Uniwersytet Jagielloński Collegium Medicum, Fakultní nemocnice Hradec Králové, European Commission, Universität Heidelberg, Institut National de la Santé et de la Recherche Médicale, Albert-Ludwigs-Universität Freiburg, Ministerstvo Zdravotnictví Ceské Republiky, Warszawski Uniwersytet Medyczny, Uniwersytet Warszawski, Assistance publique-Hôpitaux de Paris, Masarykova Univerzita, Lékařská fakulta, Masarykova univerzita, Sorbonne Université, Universitätsmedizin Mannheim, Lékařská Fakulta v Plzni, Univerzita Karlova, lékařská fakulta Univerzity Karlovy, Medizinische Fakultät der Albert-Ludwigs-Universität Freiburg
Good health and well-being
Openalex Percentile: Top 8%
Antiplatelet Therapy and Cardiovascular Diseases
2.81
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