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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
Z. Motovska, O. Hlinomaz, J. Mrozek, P. Kala, T. Geisler, M. Hromadka, I. Akin, J. Precek, J. Kettner, P. Cervinka, G. Montalescot, J. Jarkovsky, J. Belohlavek, J. Bis, J. Matejka, A. Vodzinska, T. Muzafarova, P. Tomasov, A. Schee, S. Bartus, A....
Language English Country France
Document type Clinical Trial Protocol, Journal Article
- MeSH
- Adenosine Monophosphate * analogs & derivatives therapeutic use adverse effects administration & dosage MeSH
- Purinergic P2Y Receptor Antagonists administration & dosage adverse effects therapeutic use MeSH
- Double-Blind Method MeSH
- Vasodilator-Stimulated Phosphoprotein MeSH
- Phosphoproteins MeSH
- Myocardial Infarction * complications MeSH
- Platelet Aggregation Inhibitors * adverse effects therapeutic use administration & dosage MeSH
- Shock, Cardiogenic * mortality MeSH
- Percutaneous Coronary Intervention adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Randomized Controlled Trials as Topic MeSH
- Aged MeSH
- Ticagrelor * therapeutic use administration & dosage adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
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.
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
Cardiology Department Hospital Liberec Liberec Czech Republic
Cardiology Department Institute of Clinical and Experimental Cardiology Prague 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 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 Medical University of Warsaw Warsaw Polan
Department of Cardiology Na Homolce Hospital Prague Czech Republic
Department of Cardiology Pardubice Hospital Pardubice Czech Republic
Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic
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
References provided by Crossref.org
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- $a 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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