Fig. 1: IVORY trial design and participant flow. | Nature Medicine

Fig. 1: IVORY trial design and participant flow.

From: Anti-inflammatory therapy with low-dose IL-2 in acute coronary syndromes: a randomized phase 2 trial

Fig. 1: IVORY trial design and participant flow.The alternative text for this image may have been generated using AI.

a, Design of the IVORY trial. Patients presenting with ACSs and hsCRP >2mg l−1 who passed screening were randomized to either subcutaneously administered 1.5 × 106 IU of low-dose IL-2 or placebo (volume equivalent of 5% dextrose). An [18F]FDG PET–CT scan of the ascending aorta and carotids was carried out before the start of treatment. The first dose was administered within 14 days of admission of the patient to hospital. Patients received treatment once daily for 5 days in the induction phase, followed by once-weekly injections for 7 weeks in the maintenance phase. The dosing visits were identical in the maintenance phase, except that complete blood counts, liver and renal function tests were checked before administration of IL-2 or placebo. FACS for T cell subsets was carried out within 4 h of the blood draw. Blood samples for immunological analyses and analyses of peripheral blood mononuclear cells were collected and stored at visit 3 (V3) before treatment administration, as well as at V7, V8, V10, V12, V14 and V15. V2–V16 were carried out on an outpatient basis. V16 was the last trial encounter and was performed remotely unless an in-person visit was required for safety reasons. b, Participant flow in the IVORY trial. ALT, alanine transaminase, COVID-19, coronavirus disease 2019; ULN, upper limit of normal. Created with BioRender.com.

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