Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial
| Autor: | Tian Xiao, Zhao, Michalis, Kostapanos, Charmaine, Griffiths, Emma L, Arbon, Annette, Hubsch, Fotini, Kaloyirou, Joanna, Helmy, Stephen P, Hoole, James H F, Rudd, Graham, Wood, Keith, Burling, Simon, Bond, Joseph, Cheriyan, Ziad, Mallat |
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| Rok vydání: | 2018 |
| Předmět: |
Clinical Trials
Phase I as Topic Interleukin-6 Myocardial Ischemia T-Lymphocytes Regulatory Recombinant Proteins Troponin C-Reactive Protein Clinical Trials Phase II as Topic Double-Blind Method Natriuretic Peptide Brain Humans Immunologic Factors Interleukin-2 Lymphocyte Count Acute Coronary Syndrome Randomized Controlled Trials as Topic |
| Zdroj: | BMJ open. 8(9) |
| ISSN: | 2044-6055 |
| Popis: | Inflammation and dysregulated immune responses play a crucial role in atherosclerosis, underlying ischaemic heart disease (IHD) and acute coronary syndromes (ACSs). Immune responses are also major determinants of the postischaemic injury in myocardial infarction. Regulatory T cells (CD4Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes is a single-centre, first-in-class, dose-escalation, two-part clinical trial. Patients with stable IHD (part A) and ACS (part B) will be randomised to receive either IL-2 (aldesleukin; dose range 0.3-3×10The study received a favourable opinion by the Greater Manchester Central Research Ethics Committee, UK (17/NW/0012). The results of this study will be reported through peer-reviewed journals, conference presentations and an internal organisational report.NCT03113773; Pre-results. |
| Databáze: | OpenAIRE |
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