E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1) Storage of white cells for DNA & RNA sub-study, 17/10/2006 v7. To study the genetic substrate of observed differences in inflammatory markers and also effects of IL-1ra treatment.
2) ST-Holter segment analysis sub study, 17/10/2006 v7. To determine the number of ischemic events, their frequency and total duration in both treatment groups.
3) Cardiac Magnetic Resonance Imaging sub study, 17/10/2006 v7. To evaluate the possible mechanisms of any potential benefit by investigation of myocardial function, infarct size and oedema.
4) Forearm Endothelial cell response sub study, 17/10/2006 v7. To assess differences in systemic endothelial vascular reactivity between treatment groups. |
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E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |