Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aldesleukin, Dextrose 5% in water.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndromes. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study
Overview
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.
Detailed description
A heart attack occurs when there is reduced blood flow to heart muscle cells which results from narrowings or blockages in walls of blood vessels supplying the heart, due to fatty deposits and inflammatory cells that build up over time. This build-up leads to heart muscle damage called a heart attack.
The immune system plays an important role in both the development of the narrowings and the damage to the heart muscle during a heart attack. Studies have shown that there is a lower level of protective immune cells called regulatory T-cells (Tregs) in heart attack patients. Increasing the number of circulating Tregs may have a direct effect in reducing the inflammation in arteries, preventing further narrowings in blood vessels and improving heart muscle function. Aldesleukin, also known as interleukin-2 (IL2), is a medicine that stimulates the production of Treg cells when given at low doses. The effectiveness of IL2 in influencing the immune system was tested in a phase 2 trial, IVORY.
Participants were recruited to the IVORY trial following a sudden narrowing/blockages in walls of blood vessels to the heart resulting in a heart attack (Acute Coronary Syndrome (ACS)). Participants were randomised to receive either low dose IL2 or placebo, researchers and participants were blinded to the treatment allocation. Participants underwent two PET/CT (Positron emission tomography-computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups.
Interventions
- Drug Aldesleukin
IL2 antagonist - Drug Dextrose 5% in water
matched placebo to active
Primary outcome measures
- Major adverse cardiovascular outcomes [Time frame: 1 year from when initially dosed in preceding IVORY trial]
- Major adverse cardiovascular outcomes [Time frame: 2 years from when initially dosed in preceding IVORY trial]
- Major adverse cardiovascular outcomes [Time frame: 5 years from when initially dosed in preceding IVORY trial]
Secondary outcome measures (12)
- Death due to cardiovascular causes [Time frame: 1 year from when initially dosed in preceding IVORY trial]
- Deaths due to cardiovascular causes comparing IL2 to placebo [Time frame: 2 years from when initially dosed in preceding IVORY trial]
- Deaths due to cardiovascular causes comparing IL2 to placebo [Time frame: 5 years from when initially dosed in preceding IVORY trial]
- Resuscitated cardiac arrests comparing IL2 to placebo [Time frame: 1 year from when initially dosed in preceding IVORY trial]
- Resuscitated cardiac arrests comparing IL2 to placebo [Time frame: 2 years from when initially dosed in preceding IVORY trial]
- Resuscitated cardiac arrests comparing IL2 to placebo [Time frame: 5 years from when initially dosed in preceding IVORY trial]
- Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo [Time frame: 1 year from when initially dosed in preceding IVORY trial]
- Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo [Time frame: 2 years from when initially dosed in preceding IVORY trial]
- Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo [Time frame: 5 years from when initially dosed in preceding IVORY trial]
- Ischaemic strokes comparing IL2 to placebo [Time frame: 1 year from when initially dosed in preceding IVORY trial]
- Ischaemic strokes comparing IL2 to placebo [Time frame: 2 years from when initially dosed in preceding IVORY trial]
- Ischaemic strokes comparing IL2 to placebo [Time frame: 5 years from when initially dosed in preceding IVORY trial]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Addenbrooke's Hospital — Cambridge
Identifiers
NCT: NCT06427694 · IVORY-FINALE (A096877) · 339102