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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
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. CONDITION: Non‐ST elevation acute coronary syndromes ; Circulatory System ; Coronary syndromes PRIMARY OUTCOME: Area under the curve of serum high sensitivity C‐Reactive Protein (hsCRP) over the first seven days. SECONDARY OUTCOME: 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 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
Epistemonikos ID: f76bb5a990b3f617e01811a79f9e2fcc1b991047
First added on: Aug 21, 2024