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

    jc403@medschl.cam.ac.uk

  • 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