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Studies in preclinical models have demonstrated that an increase in regulatory T cells (Tregs), which have a potent immune modulatory action, led to a regression of atherosclerosis. The Low-dose InterLeukin 2 (IL-2) in patients with stable ischaemic heart disease and Acute Coronary Syndromes (LILACS) study, established the safety of low-dose IL-2 and its biological efficacy in IHD. The IVORY trial is designed to assess the effects of low-dose IL-2 on vascular inflammation in patients with acute coronary syndromes (ACS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      In this study, we hypothesise that low-dose IL-2 will reduce vascular inflammation in patients presenting with ACS. This is a double-blind, randomised, placebo-controlled, phase II clinical trial. Patients will be recruited across two centres, a district general hospital and a tertiary cardiac centre in Cambridge, UK. Sixty patients with ACS (unstable angina, non-ST elevation myocardial infarction or ST elevation myocardial infarction) with high-sensitivity C reactive protein (hsCRP) levels &gt;2\u2009mg\/L will be randomised to receive either 1.5\u00d710\n                      <jats:sup>6<\/jats:sup>\n                      \u2009IU of low-dose IL-2 or placebo (1:1). Dosing will commence within 14 days of admission. Dosing will comprise of an induction and a maintenance phase. 2-Deoxy-2-[fluorine-18] fluoro-D-glucose (\n                      <jats:sup>18<\/jats:sup>\n                      F-FDG) positron emission tomography\/CT (PET\/CT) scans will be performed before and after dosing. The primary endpoint is the change in mean maximum target to background ratios (TBR\n                      <jats:sub>max<\/jats:sub>\n                      ) in the index vessel between baseline and follow-up scans. Changes in circulating T-cell subsets will be measured as secondary endpoints of the study. The safety and tolerability of extended dosing with low-dose IL-2 in patients with ACS will be evaluated throughout the study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The Health Research Authority and Health and Care Research Wales, UK (19\/YH\/0171), approved the study. Written informed consent is required to participate in the trial. The results will be reported through peer-reviewed journals and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04241601\">NCT04241601<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-062602","type":"journal-article","created":{"date-parts":[[2022,10,7]],"date-time":"2022-10-07T12:12:53Z","timestamp":1665144773000},"page":"e062602","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":46,"title":["Low-dose\n                    <i>i<\/i>\n                    nterleukin 2 for the reduction of\n                    <i>v<\/i>\n                    ascular inflammati\n                    <i>o<\/i>\n                    n in acute corona\n                    <i>ry<\/i>\n                    syndromes (IVORY): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase II clinical trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04241601","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9515-1201","authenticated-orcid":false,"given":"Rouchelle","family":"Sriranjan","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0202-5255","authenticated-orcid":false,"given":"Tian Xiao","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Cardiovascular Medicine, University of Cambridge, Cambridge, 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