Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04241601
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2019-12-09
Brief Title:
Low-dose Interleukin-2 for the Reduction of Vascular Inflammation in Acute Coronary Syndromes - IVORY
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Cambridge University Hospitals NHS Foundation Trust
Study Overview
Official Title:
Low-dose Interleukin-2 for the Reduction of Vascular Inflammation in Acute Coronary Syndromes
Status:
COMPLETED
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
Brief Summary:
Acute coronary syndromes ACS result from coronary plaques disruption which initiates a thrombotic process leading to partial or complete obstruction of the vessel lumen with subsequent myocardial ischaemia and necrosis The mainstay of treatment is currently focused on the re-establishment and maintenance of coronary artery patency using anti-platelets and anticoagulants with or without mechanical dilatation and stenting of the culprit artery Despite important advances in management ACS still carries a risk of substantial morbidity and mortality The improved efficacy of novel anti-platelet and anticoagulant agents have been limited by increased risk of haemorrhagic events Future breakthroughs in management are most likely to arise from targeting other relevant pathophysiological pathways Particularly the immune response which is an important process that has been neglected in the management of patients with ACS
In this trial the investigators investigate the efficacy of low dose IL-2 compared with placebo in patients with ACS
In this trial the investigators investigate the efficacy of low dose IL-2 compared with placebo in patients with ACS
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 IL-2 is a medicine that stimulates the production of Treg cells when given at low doses and is the drug being tested in this trial IL-2 is licensed for the treatment of kidney cancer where it is given at much higher doses than planned in this trial It appears to be safe and well tolerated at low doses while increasing Treg cells
IVORY will be conducted in patients presenting with a heart attack Acute Coronary Syndrome ACS Approximately 60 patients will be randomized to receive either low dose IL-2 or placebo It is a Phase 2 randomised double- blinded placebo-controlled experimental trial Total study duration for each participant will be approximately 13 weeks
Participants will undergo two PETCT Positron emission tomography-computed tomography scans to observe change of inflammation in the blood vessels from baseline between the two trial groups Primary Endpoint
Aldesleukin also known as interleukin-2 IL-2 is a medicine that stimulates the production of Treg cells when given at low doses and is the drug being tested in this trial IL-2 is licensed for the treatment of kidney cancer where it is given at much higher doses than planned in this trial It appears to be safe and well tolerated at low doses while increasing Treg cells
IVORY will be conducted in patients presenting with a heart attack Acute Coronary Syndrome ACS Approximately 60 patients will be randomized to receive either low dose IL-2 or placebo It is a Phase 2 randomised double- blinded placebo-controlled experimental trial Total study duration for each participant will be approximately 13 weeks
Participants will undergo two PETCT Positron emission tomography-computed tomography scans to observe change of inflammation in the blood vessels from baseline between the two trial groups Primary Endpoint
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-005130-27 | EUDRACT_NUMBER | None | None |