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NCT Number: NCT06427694

Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

Location status: Recruiting

Location contact

Joseph Cheriyan, MBChB, FRCP

PRINCIPAL_INVESTIGATOR

Joseph Cheriyan, MBChB,FRCP

CONTACT

[email protected]

0044 1223 256653

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldesleukin

Drug

IL2 antagonist

Other names: Proleukin

Dextrose 5% in water

Drug

matched placebo to active

Other names: Dextrose

Primary outcomes

  1. Major adverse cardiovascular outcomes

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of major adverse cardiovascular outcomes

  2. Major adverse cardiovascular outcomes

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of major adverse cardiovascular outcomes

  3. Major adverse cardiovascular outcomes

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of major adverse cardiovascular outcomes

Secondary outcomes

  1. Death due to cardiovascular causes

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of deaths due to cardiovascular causes comparing IL2 to placebo

  2. Deaths due to cardiovascular causes comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of deaths due to cardiovascular causes comparing IL2 to placebo

  3. Deaths due to cardiovascular causes comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of deaths due to cardiovascular causes comparing IL2 to placebo

  4. Resuscitated cardiac arrests comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Numbers of resuscitated cardiac arrests comparing IL2 to placebo

  5. Resuscitated cardiac arrests comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Numbers of resuscitated cardiac arrests comparing IL2 to placebo

  6. Resuscitated cardiac arrests comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Numbers of resuscitated cardiac arrests comparing IL2 to placebo

  7. Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo

  8. Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo

  9. Non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of non-fatal MI (including NSTEMI and STEMI) comparing IL2 to placebo

  10. Ischaemic strokes comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of ischaemic strokes comparing IL2 to placebo

  11. Ischaemic strokes comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of ischaemic strokes comparing IL2 to placebo

  12. Ischaemic strokes comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of ischaemic strokes comparing IL2 to placebo

  13. Unplanned coronary vascularisations comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of unplanned coronary vascularisations comparing IL2 to placebo

  14. Unplanned coronary vascularisations comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of unplanned coronary vascularisations comparing IL2 to placebo

  15. Unplanned coronary vascularisations comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of unplanned coronary vascularisations comparing IL2 to placebo

  16. Hospitalisations due to cardiovascular causes comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo

  17. Hospitalisations due to cardiovascular causes comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo

  18. Hospitalisations due to cardiovascular causes comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of hospitalisations due to cardiovascular causes comparing IL2 to placebo

  19. All-cause deaths comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of all-cause deaths comparing IL2 to placebo

  20. All-cause death comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of all-cause deaths comparing IL2 to placebo

  21. All-cause death comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of all-cause deaths comparing IL2 to placebo

  22. Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo

  23. Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure)comparing IL2 to placebo

  24. Hospitalisations due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of hospitalisation due to symptoms from heart failure (incl admission due to pulmonary oedema and congestive heart failure) comparing IL2 to placebo

  25. Revascularisations for peripheral vascular disease comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of revascularisations for peripheral vascular disease comparing IL2 to placebo

  26. Revascularisations for peripheral vascular disease comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of revascularisations for peripheral vascular diseasecomparing IL2 to placebo

  27. Revascularisations for peripheral vascular disease comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of revascularisations for peripheral vascular disease comparing IL2 to placebo

  28. Amputations due to peripheral vascular disease comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of amputations due to peripheral vascular disease comparing IL2 to placebo

  29. Amputations due to peripheral vascular disease comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of amputations due to peripheral vascular disease comparing IL2 to placebo

  30. Amputations due to peripheral vascular disease comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of amputations due to peripheral vascular disease comparing IL2 to placebo

  31. Haemorrhagic strokes comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of haemorrhagic strokes comparing IL2 to placebo

  32. Haemorrhagic strokes comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of haemorrhagic strokes comparing IL2 to placebo

  33. Haemorrhagic strokes comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of haemorrhagic strokes comparing IL2 to placebo

  34. New atrial fibrillation diagnosis comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of new atrial fibrillation diagnoses comparing IL2 to placebo

  35. New atrial fibrillation diagnosis comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of new atrial fibrillation diagnoses comparing IL2 to placebo

  36. New atrial fibrillation diagnosis comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of new atrial fibrillation diagnoses comparing IL2 to placebo

  37. Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo

    Time frame: 1 year from when initially dosed in preceding IVORY trial

    Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo

  38. Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo

    Time frame: 2 years from when initially dosed in preceding IVORY trial

    Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo

  39. Ventricular arrhythmia (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo

    Time frame: 5 years from when initially dosed in preceding IVORY trial

    Number of ventricular arrhythmia episodes (sustained ventricular tachycardia and ventricular fibrillation) comparing IL2 to placebo

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study

Acronym: IVORY-FINALE

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
May 24, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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