The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.
In this follow-up study, the investigators aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.
Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses
Patients who decline participation
Patients who did not consent to being contacted about future research
Patients who were withdrawn from the IVORY trial for any reason
Participants of the IVORY trial (NCT04241601) and who consented to be contacted for future research received all scheduled doses of either placebo or IL2 and are alive at the time of data collection will be approached.
Cohort
Prospective
Aldesleukin
DrugIL2 antagonist
Dextrose 5% in water
Drugmatched placebo to active
Major adverse cardiovascular outcomes
Number of major adverse cardiovascular outcomes
Major adverse cardiovascular outcomes
Number of major adverse cardiovascular outcomes
Major adverse cardiovascular outcomes
Number of major adverse cardiovascular outcomes
Death due to cardiovascular causes
Number of deaths due to cardiovascular causes comparing IL2 to placebo
Deaths due to cardiovascular causes comparing IL2 to placebo
Number of deaths due to cardiovascular causes comparing IL2 to placebo
Deaths due to cardiovascular causes comparing IL2 to placebo
Number of deaths due to cardiovascular causes comparing IL2 to placebo
Resuscitated cardiac arrests comparing IL2 to placebo
Numbers of resuscitated cardiac arrests comparing IL2 to placebo
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