Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427694
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-20
Brief Title:
Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes Follow-up Study
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVORY-FINALE
Brief 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 eg stable and unstable angina TIAs heart failure amputations and revascularisation due to peripheral vascular disease
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 eg 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 narrowingblockages 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 PETCT Positron emission tomography-computed tomography scans to observe change of inflammation in the blood vessels from baseline between the two trial groups
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 narrowingblockages 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 PETCT Positron emission tomography-computed tomography scans to observe change of inflammation in the blood vessels from baseline between the two trial groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 339102 | OTHER | IRAS | None |