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

NCT06427694 | Recruiting

• 2 other identifiers: IVORY-FINALE (A096877)339102
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.

Conditions

Acute Coronary Syndromes

Keywords

Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (3)

• Major adverse cardiovascular outcomes

  Number of major adverse cardiovascular outcomes

  1 year from when initially dosed in preceding IVORY trial

• Major adverse cardiovascular outcomes

  Number of major adverse cardiovascular outcomes

  2 years from when initially dosed in preceding IVORY trial

• Major adverse cardiovascular outcomes

  Number of major adverse cardiovascular outcomes

  5 years from when initially dosed in preceding IVORY trial

Secondary Outcomes (39)

• Death due to cardiovascular causes

  1 year from when initially dosed in preceding IVORY trial

• Deaths due to cardiovascular causes comparing IL2 to placebo

  2 years from when initially dosed in preceding IVORY trial

• Deaths due to cardiovascular causes comparing IL2 to placebo

  5 years from when initially dosed in preceding IVORY trial

• Resuscitated cardiac arrests comparing IL2 to placebo

  1 year from when initially dosed in preceding IVORY trial

• Resuscitated cardiac arrests comparing IL2 to placebo

  2 years from when initially dosed in preceding IVORY trial

Study Arms (2)

Aldesleukin

Aldesleukin loading dose 1.5 x 10\^6 IU followed by maintenance dose of 1.5 x 10\^6 IU

Drug: Aldesleukin

Placebo

Dextrose 5%

Drug: Dextrose 5% in water

Interventions

Aldesleukin DRUG

IL2 antagonist

Also known as: Proleukin

Aldesleukin

Dextrose 5% in water DRUG

matched placebo to active

Also known as: Dextrose

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of the IVORY trial (NCT04241601) and who consented to be contacted for future research received all scheduled doses of either placebo or IL2 and are alive at the time of data collection will be approached.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

aldesleukin; Glucose; Water

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Joseph Cheriyan, MBChB, FRCP

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Joseph Cheriyan, Consultant Clinical Pharmacologist/Affilitated Associate Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): February 11, 2030
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)