Zuzana Motovska; Ota Hlinomaz; Jan Mrozek; Petr Kala; Tobias Geisler; Milan Hromadka; Ibrahim Akin; Jan Precek; Jiri Kettner; Pavel Cervinka; Gilles Montalescot; Jiři Jarkovsky; Jan Belohlavek; Josef Bis; Jan Matejka; Alexandra Vodzinska; Tamilla Muzafarova; Pavol Tomasov; Alexander Schee; Stanislav Bartus; Andrea Andrasova; Christoph Olivier; Ales Kovarik; Petr Ostadal; Regina Demlova; Lenka Souckova; Ivan Vulev; Zdeněk Coufal; Janusz Kochman; Iuri Marinov; Jacek Kubica; Gregory Ducrocq; Michal Karpisek; Zdenek Klimsa; Martin Hudec; Petr Widimský; Deepak Bhatt; DAPT-SHOCKAMI group

doi:10.4244/EIJ-D-24-00203

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

The reference multimedia journal in interventional cardiology

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

1. Cardiocentre, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic; 2. First Department of Internal Medicine – Cardioangiology, ICRC, Faculty of Medicine, Masaryk University and St. Anne’s University Hospital, Brno, Czech Republic; 3. CINRE, Bratislava, Slovak Republic; 4. Cardiovascular Department, University Hospital Ostrava and Faculty of Medicine, University Ostrava, Ostrava, Czech Republic; 5. Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital Brno, Brno, Czech Republic; 6. Department of Cardiology and Angiology, University Hospital/Eberhard Karls University, Tübingen, Germany; 7. Department of Cardiology, University Hospital and Faculty of Medicine in Pilsen, Charles University, Pilsen, Czech Republic; 8. First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany; 9. Department of Internal Medicine I – Cardiology, Faculty of Medicine and Dentistry, Palacky University and University Hospital, Olomouc, Olomouc, Czech Republic; 10. Cardiology Department, Institute of Clinical and Experimental Cardiology, Prague, Czech Republic; 11. Department of Cardiology, Krajska zdravotni a.s., Masaryk Hospital and Jan Evangelista Purkyně University, Ústí nad Labem, Czech Republic; 12. 1st. Department of Medicine – Cardioangiology, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic; 13. Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (Assistance Publique-Hôpitaux de Paris), Paris, France; 14. Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic; 15. Second Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic; 16. Department of Cardiology, Pardubice Hospital, Pardubice, Czech Republic; 17. Department of Cardiology, Hospital Agel Trinec-Podlesi, Trinec, Czech Republic; 18. Cardiology Department, Hospital Liberec, Liberec, Czech Republic; 19. Cardiocenter, Regional Hospital Karlovy Vary, Karlovy Vary, Czech Republic; 20. Institute of Cardiology, Jagiellonian University Medical College, Kraków, Poland and Department of Cardiology, University Hospital, Kraków, Poland; 21. Cardiocenter Nitra, Nitra, Slovak Republic; 22. Cardiovascular Clinical Research Center (CCRC), Department of Cardiology and Angiology, University Heart Center Freiburg – Bad Krozingen, Faculty of Medicine, University of Freiburg, Freiburg, Germany; 23. Cardiocenter, Regional Hospital Ceske Budejovice, Ceske Budejovice, Czech Republic; 24. Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic; 25. Department of Cardiology, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic; 26. CZECRIN, Faculty of Medicine, Masaryk University and St. Anne’s University Hospital, Brno, Czech Republic; 27. T. Bata Regional Hospital Zlin, Zlin, Czech Republic; 28. Department of Cardiology, Medical University of Warsaw, Warsaw, Polan; 29. Institute of Hematology and Blood Transfusion, Prague, Czech Republic; 30. Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland; 31. Department of Cardiology, FACT (French Alliance for Cardiovascular Trials), DHU-FIRE, Bichat-Claude Bernard University Hospital, Paris, France; 32. BioVendor R&D, BioVendor-Laboratory Medicine, Brno, Czech Republic; 33. Department of Cardiology, Jihlava Hospital, Jihlava, Czech Republic; 34. Department of Acute Cardiology, SUSCCH, Banska Bystrica, Slovak Republic; 35. Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA

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.

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