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
Jazyk angličtina Země Francie Médium electronic
Typ dokumentu protokol klinické studie, časopisecké články
PubMed
39432252
PubMed Central
PMC11472137
DOI
10.4244/eij-d-24-00203
PII: EIJ-D-24-00203
Knihovny.cz E-zdroje
- MeSH
- adenosinmonofosfát * analogy a deriváty terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- dvojitá slepá metoda MeSH
- fosfoproteiny MeSH
- infarkt myokardu * komplikace MeSH
- inhibitory agregace trombocytů * škodlivé účinky terapeutické užití aplikace a dávkování MeSH
- kardiogenní šok * mortalita MeSH
- koronární angioplastika škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- purinergní receptory P2Y - antagonisté aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři MeSH
- ticagrelor * terapeutické užití aplikace a dávkování škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- Názvy látek
- adenosinmonofosfát * MeSH
- cangrelor MeSH Prohlížeč
- fosfoproteiny MeSH
- inhibitory agregace trombocytů * MeSH
- purinergní receptory P2Y - antagonisté MeSH
- ticagrelor * MeSH
- Vasodilator-Stimulated Phosphoprotein 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
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ClinicalTrials.gov
NCT03551964