Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study
Recruiting now · Has a placebo group
Conditions studied: Acute Coronary Syndromes
In brief
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.
Key facts
- Study ID
- NCT06427694
- Run by
- Cambridge University Hospitals NHS Foundation Trust
- People needed
- 60
- Starts
- 2024-06-01
- Expected to finish
- 2030-02-11
- Last updated by the study team
- 2024-06-10
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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- Patients who were withdrawn from the IVORY trial for any reason
Where it is running
- Addenbrooke's Hospital — Cambridge, Cambridgeshire, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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