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ANalgesic Efficacy and safety of MOrphiNe versus methoxyflurane in patients with acute myocardial infarction: the rationale and design of the ANEMON-SIRIO 3 study: a multicentre, open-label, phase II, randomised clinical trial.
Kubica, Aldona; Kosobucka, Agata; Niezgoda, Piotr; Adamski, Piotr; Buszko, Katarzyna; Lesiak, Maciej; Wojakowski, Wojciech; Gasior, Mariusz; Goracy, Jaroslaw; Kleinrok, Andrzej; Nadolny, Klaudiusz; Navarese, Eliano; Kubica, Jacek.
Afiliación
  • Kubica A; Departament of Health Promotion, Nicolaus Copernicus University in Torun Ludwik Rydygier Collegium Medicum, Bydgoszcz, Poland.
  • Kosobucka A; Departament of Health Promotion, Nicolaus Copernicus University in Torun Ludwik Rydygier Collegium Medicum, Bydgoszcz, Poland akosobucka@wp.pl.
  • Niezgoda P; Department of Cardiology and Internal Medicine, Nicolaus Copernicus University in Torun Ludwik Rydygier Collegium Medicum, Bydgoszcz, Poland.
  • Adamski P; Department of Cardiology and Internal Medicine, Nicolaus Copernicus University in Torun Ludwik Rydygier Collegium Medicum, Bydgoszcz, Poland.
  • Buszko K; Department of Theoretical Foundations of Biomedical Science and Medical Informatics, Nicolaus Copernicus University in Torun Ludwik Rydygier Collegium Medicum, Bydgoszcz, Poland.
  • Lesiak M; The 1st Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland.
  • Wojakowski W; Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
  • Gasior M; 3rd Department of Cardiology, School of Medicine with the Division of Dentistry, Medical University of Silesia, Zabrze, Poland.
  • Goracy J; Department of Cardiology, Pomeranian Medical University in Szczecin, Szczecin, Poland.
  • Kleinrok A; Department of Cardiology, Pope John Paul II Reginal Hospital, Zamosc, Poland.
  • Nadolny K; Medical Department, University of Information Technology and Management, Rzeszow, Poland.
  • Navarese E; Department of Emergency Medicine and Disasters, Medical University of Bialystok, Bialystok, Poland.
  • Kubica J; Department of Emergency Medical Service, Higher School of Strategic Planning, Dabrowa Górnicza, Poland.
BMJ Open ; 11(3): e043330, 2021 03 01.
Article en En | MEDLINE | ID: mdl-33649058
INTRODUCTION: The unfavourable influence of morphine on the pharmacokinetics of ticagrelor resulting in weaker and retarded antiplatelet effect in patients with acute coronary syndrome (ACS) has been previously shown. Replacing morphine with methoxyflurane, a potent, non-opioid analgesic agent, that does not weaken or delay the effect of antiplatelet agents may improve the clinical efficacy of treatment of patients with ACS. METHODS: The ANEMON-SIRIO 3 study was designed as a multicentre, open-label, phase II, randomised clinical trial aimed to test the analgesic efficacy and safety of methoxyflurane in patients with ACS. The study population will comprise patients with ST-elevation myocardial infarction or non-ST-elevation ACS admitted to the study centres with typical chest pain requiring analgesic treatment. Before percutaneous coronary intervention (PCI) for the patients with index ACS will be randomly assigned in 1:1 ratio to receive methoxyflurane administered by inhalation, or to obtain morphine administered intravenously. Analgesic treatment will be followed by 300 mg loading dose of aspirin and 180 mg loading dose of ticagrelor. Patients will be assessed with regard to pain intensity according to the Numeric Pain Rating Scale at baseline, 3 min after study drug administration and immediately after PCI. Moreover, patients will be actively monitored with regard to the occurrence of side effects of evaluated therapies, as well as adverse events that may be related to insufficient platelet inhibition (no-reflow phenomenon assessed immediately after PCI, administration of GPIIb/IIIa inhibitors during PCI, acute stent thrombosis). ETHICS AND DISSEMINATION: The study will be conducted in six Polish clinical centres from the beginning of in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov, NCT04476173.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome Coronario Agudo / Intervención Coronaria Percutánea / Infarto del Miocardio Tipo de estudio: Clinical_trials / Guideline Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2021 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome Coronario Agudo / Intervención Coronaria Percutánea / Infarto del Miocardio Tipo de estudio: Clinical_trials / Guideline Aspecto: Ethics Límite: Humans Idioma: En Revista: BMJ Open Año: 2021 Tipo del documento: Article País de afiliación: Polonia Pais de publicación: Reino Unido