Investigation of the effect of InterLeukin-1 receptor Antagonist on markers of inflammation in non-ST elevation acute coronary syndromes

ISRCTN	ISRCTN89369318
DOI	https://doi.org/10.1186/ISRCTN89369318
Protocol serial number	101105
Sponsor	University of Sheffield (UK)
Funder	Medical Research Council grant award (ref no: G0502131)

Submission date: 10/08/2006
Registration date: 03/10/2006
Last edited: 26/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Crossman
Scientific

Cardiovascular Research Unit
School of Medicine & Biomedical Sciences
University of Sheffield
Beech Hill Road
Sheffield
S10 2RX
United Kingdom

Phone	+44 (0) 114 2261432
Email	d.c.crossman@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double blind placebo controlled multi-centre phase II clinical trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MRC-ILA-HEART study
Study objectives	Does treatment of Non-ST Elevation Myocardial Infarction (NSTEMI)/Acute Coronary Syndrome (ACS) with InterLeukin-1 receptor antagonist (IL-1ra) alter the inflammatory process involved in this condition?
Ethics approval(s)	Leeds (West) Research Ethics Committee, 18th December 2006, ref: 06/Q1205/234.
Health condition(s) or problem(s) studied	Non-ST elevation acute coronary syndromes
Intervention	Eligible patients will be randomised in equal proportions between IL-1ra and placebo, receiving either a once daily, subcutaneous (s.c.) injection of IL-1ra (dose 100 mg per 24 hours) for 14 days, or a daily s.c. injection of placebo for 14 days.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	InterLeukin-1 receptor antagonist
Primary outcome measure(s)	Area under the curve of serum high sensitivity C-Reactive Protein (hsCRP) over the first seven days.
Key secondary outcome measure(s)	1. Mean hsCRP at seven, 14 and 30 days 2. Area under the curve of Troponin-I 3. von Willebrand Factor (vWF) and InterLeukin-6 (IL-6) 4. ST segment depression on Holter monitor 5. Myocardial injury as determined by Gadolinium enhanced Cardiovascular Magnetic Resonance (CMR) scan 6. Forearm endothelial cell response 7. Incidence of Major Adverse Cardiovascular Events (MACE) at 30 days, three months and at one year 8. Flagging with Office of National Statistics (ONS) for up to five years
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	186
Key inclusion criteria	1. Aged over 18 years of age 2. Acute severe cardiac chest pain consistent with an acute coronary syndrome 3. Less than 48 hours from onset of symptoms that led to hospital admissions 4. And at least one of the following: a. Horizontal or down-sloping ST depression of at least 0.5mm in at least two Electrocardiogram (ECG) leads b. a raised troponin as defined by local parameters specified at each centre c. Other ECG changes consistent with acute myocardial ischaemia (e.g. T-wave inversion of at least 3 mm, 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
Key exclusion criteria	1. Less than 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 three months 5. Previous coronary artery bypass grafting 6. ECG showing paced rhythm 7. Cardiogenic shock (as defined in the Trial Manual) 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 more than 220 µmol/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-Tumour Necrotising Factor (TNF) biologies 14. Active infection 15. Malignancy
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cardiovascular Research Unit

Sheffield
S10 2RX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/02/2008		Yes	No