RecruitingNCT06427694

Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study

The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

60 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria1

  • 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

Exclusion Criteria3

  • 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  • Patients who were withdrawn from the IVORY trial for any reason

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Interventions

DRUGAldesleukin

IL2 antagonist

DRUGDextrose 5% in water

matched placebo to active


Locations(1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

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