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

. 2024 Oct 21 ; 20 (20) : e1309-e1318. [epub] 20241021

Jazyk angličtina Země Francie Médium electronic

Typ dokumentu protokol klinické studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid39432252

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.

1st Department of Internal Medicine Cardioangiology ICRC Faculty of Medicine Masaryk University and St Anne's University Hospital Brno Czech Republic

1st Department of Medicine Cardioangiology University Hospital Hradec Kralove Hradec Kralove Czech Republic

1st Department of Medicine University Medical Centre Mannheim Faculty of Medicine Mannheim University of Heidelberg Mannheim Germany

2nd Department of Internal Medicine Cardiovascular Medicine General Teaching Hospital 1st Faculty of Medicine Charles University Prague Czech Republic

BioVendor R and D BioVendor Laboratory Medicine Brno Czech Republic

Cardiocenter Nitra Nitra Slovak Republic

Cardiocenter Regional Hospital Ceske Budejovice Ceske Budejovice Czech Republic

Cardiocenter Regional Hospital Karlovy Vary Karlovy Vary Czech Republic

Cardiocentre 3rd Faculty of Medicine Charles University and University Hospital Kralovske Vinohrady Prague Czech Republic

Cardiology Department Hospital Liberec Liberec Czech Republic

Cardiology Department Institute of Clinical and Experimental Cardiology Prague Czech Republic

Cardiovascular Clinical Research Center Department of Cardiology and Angiology University Heart Center Freiburg Bad Krozingen Faculty of Medicine University of Freiburg Freiburg Germany

Cardiovascular Department University Hospital Ostrava and Faculty of Medicine University Ostrava Ostrava Czech Republic

CINRE Bratislava Slovak Republic

CZECRIN Faculty of Medicine Masaryk University and St Anne's University Hospital Brno Czech Republic

Department of Acute Cardiology SUSCCH Banska Bystrica Slovak Republic

Department of Cardiology 2nd Faculty of Medicine Charles University and Motol University Hospital Prague Czech Republic

Department of Cardiology and Angiology University Hospital Eberhard Karls University Tübingen Germany

Department of Cardiology and Internal Medicine Collegium Medicum Nicolaus Copernicus University Bydgoszcz Poland

Department of Cardiology FACT DHU FIRE Bichat Claude Bernard University Hospital Paris France

Department of Cardiology Hospital Agel Trinec Podlesi Trinec Czech Republic

Department of Cardiology Jihlava Hospital Jihlava Czech Republic

Department of Cardiology Krajska zdravotni a s Masaryk Hospital and Jan Evangelista Purkyně University Ústí nad Labem Czech Republic

Department of Cardiology Medical University of Warsaw Warsaw Polan

Department of Cardiology Na Homolce Hospital Prague Czech Republic

Department of Cardiology Pardubice Hospital Pardubice Czech Republic

Department of Cardiology University Hospital and Faculty of Medicine in Pilsen Charles University Pilsen Czech Republic

Department of Internal Medicine 1 Cardiology Faculty of Medicine and Dentistry Palacky University and University Hospital Olomouc Olomouc Czech Republic

Department of Internal Medicine and Cardiology Faculty of Medicine of Masaryk University and University Hospital Brno Brno Czech Republic

Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic

Institute of Cardiology Jagiellonian University Medical College Kraków Poland and Department of Cardiology University Hospital Kraków Poland

Institute of Hematology and Blood Transfusion Prague Czech Republic

Mount Sinai Fuster Heart Hospital Icahn School of Medicine at Mount Sinai New York NY USA

Sorbonne Université ACTION Study Group INSERM UMRS 1166 Institut de Cardiologie Pitié Salpêtrière Hospital Paris France

T Bata Regional Hospital Zlin Zlin Czech Republic

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