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Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes - MRC-ILA-HEART study

Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes - MRC-ILA-HEART study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001767-31-GB
Enrollment
186
Registered
2008-02-20
Start date
2007-03-21
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

We wish to investigate Acute coronary syndromes (ACS). These are caused by blockages in the main arteries that supply the heart as a result of a process called atherosclerosis. These blockages prevent blood flow down the artery and therefore prevent the heart muscle getting the blood and oxygen that it needs to survive and function. They account for 15% of all deaths in the UK and are associated with considerable long term consequences among survivors. MedDRA version: 8.1

Interventions

Trade Name: Kineret Product Name: Kineret Pharmaceutical Form: Solution for injection INN or Proposed INN: ANAKINRA CAS Number: 14309092

Sponsors

University of Sheffield
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Acute severe cardiac chest pain consistent with an acute coronary syndrome 2) =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) 220µmol/L 11) Pregnancy or suspected pregnancy (any potential female participant of child bearing age will need a negative pregnancy test prior to study entry) 12) Eosinophilia 13) anti-TNF biologies 14) Active infection 15) Malignancy

Design outcomes

Primary

MeasureTime frame
Secondary Objective: ;Primary end point(s): The primary endpoint will be the difference in the area under the curve of serum hsCRP over the first 7 days between the treatment and the placebo group. ;Main Objective: To determine whether treatment of Acute Coronary Syndrome (ACS) /Non ST Elevation mycardial infarction (ACS are classified by the presenting ECG: patients with persistent ST elevation myocardial infarction (STEMI) generally require early reperfusion, whereas those with non ST-elevation (NSTEMI) ACS require early risk stratification and revascularisation as necessary). with IL-1ra alter the inflammatory process involved in this condition

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026