IVORY
Research type
Research Study
Full title
Low-dose interleukin-2 for the reduction of vascular inflammation in Acute Coronary Syndromes (IVORY)
IRAS ID
220945
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eudract number
2017-005130-27
Duration of Study in the UK
3 years, 1 months, 8 days
Research summary
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 diagnosed with narrowings/blockages in walls of blood vessels to the heart (Acute Coronary Syndrome (ACS)). 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 10 weeks. Participants will undergo two non-invasive vascular imaging scans (echogram or ECHO) and two invasive PET/CT (Positron emission tomography–computed tomography) scans to observe change of inflammation in the blood vessels from baseline between the two trial groups. A series of other medical assessments will also be carried out during this time.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0171
Date of REC Opinion
21 Jun 2019
REC opinion
Favourable Opinion