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

Phase 1

• 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 Level: PT Classification code 10051592 Term: Acute coronary syndrome

• Registration Number: EUCTR2006-001767-31-GB
• Lead Sponsor: niversity of Sheffield

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 186

Inclusion Criteria

1) Acute severe cardiac chest pain consistent with an acute coronary syndrome
2) <48 hours from onset of symptoms that led to hospital admission
And at least one of the following:
i) Horizontal or down-sloping ST depression of at least 0.5mm in at least 2 ECG leads
ii) A raised troponin as defined by local parameters specified at each centre
iii) Other ECG changes consistent with acute myocardial ischaemia (e.g.T-wave inversion of at least 3mm, in at least two leads of the ECG, or new onset bundle branch block) and an elevated level of Troponin above local laboratory values indicating myocardial damage

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) < 18 years of age
2) Persistent ST elevation on the presenting ECG
3) Intention to treat with an urgent reperfusion strategy (thrombolysis or primary percutaneous coronary intervention)
4) Percutaneous coronary intervention within previous 3 months
5) Previous coronary artery bypass grafting
6) ECG showing paced rhythm
7) Cardiogenic shock
8) Any serious co-morbidity which makes it unlikely that the patient will complete trial procedures and follow-up
9) Treatment or under active follow-up for rheumatoid arthritis, other connective tissue diseases or inflammatory bowel disease
10) End stage renal disease or a Creatinine > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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