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IntroductionThe 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.MethodsThe 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 disseminationThe 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 detailsClinicalTrials.gov, NCT04476173.

IntroductionAccording to the common definition, nutraceuticals are components found in food that can act as therapeutic substances. Recently, the International Lipid Expert Panel published two position papers covering the topic of lipid-lowering nutraceuticals and their potential use as a complementary treatment in addition to statins or as an alternative treatment in statin-intolerant patients. The aim of this study was to compare the effect of different nutraceuticals on lipid profiles in a systematic review with pairwise and network meta-analyses.Methods and analysisThree databases, including PubMed, Embase and the Cochrane Central Register of Controlled Trials, will be searched without time or publication language restrictions. The estimated end date for the searches will be 29 March 2020. Each stage of the review, including the study section, data extraction, and risk of bias and quality of evidence assessments, will be performed in duplicate. Randomised controlled trials meeting the following criteria will be eligible for inclusion: (1) participants aged ≥18 years, (2) intervention with a selected nutraceutical (artichoke, berberine, bergamot, soluble fibres, green tea, garlic, lupin, plant sterols and stanols, red yeast rice, soybean, spirulina or a combination of the aforementioned nutraceuticals), (3) administration of the treatment in the form of capsules, pills, powders, solutions, tablets or enriched food items, (4) comparison with another nutraceutical or placebo, (5) intervention period ≥3 weeks and (6) lipid profile (low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total cholesterol, triglycerides) as an outcome. Random-effect pairwise and network meta-analyses will be used to summarise the relative effect of each nutraceutical in comparison to the effect of every other nutraceutical. Subgroup analyses will be stratified by age, sex, ethnicity, sample size, length of trial follow-up, baseline cholesterol level and presence of other comorbidities.Ethics and disseminationThis review will summarise findings from primary studies, and therefore no ethics approval is required. The results will be presented at conferences as well as published in a peer-reviewed journal.PROSPERO registration numberCRD42019132877.