Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06427694

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

Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2024-06-10

60

Participants Needed

1

Research Sites

297 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 and who have already passed away at the start of this follow-up study
Not Eligible

You will not qualify if you...

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  • Patients who were withdrawn from the IVORY trial for any reason

AI-Screening

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Trial Site Locations

Total: 1 location

1

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom, CB20QQ

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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