E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Following as ST-wave elevation myocardial infarction, there is local ischemia. When reperfusion occurs, there is a complement mediated inflammatory reponse, known as reperfusion injury, and a systemic inflammatory response. The outcome of these responses is clinically manifested as morbidity and mortality. It is hypothesised that pexelizumab reduces these responses. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000891 |
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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 pexelizumab treatment reduces all-cause mortality at Day 90 in patients with acute ST elevation myocardial infarction (STEMI) who were expected to undergo primary percutaneous coronary intervention (PCI). |
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E.2.2 | Secondary objectives of the trial |
To determine whether pexelizumab treatment in patients with acute STEMI expected to undergo primary PCI reduces: • death through Day 180; • cardiogenic shock through Day 90; • CHF through Day 90.
The safety of intravenously administered pexelizumab in patients with AMI will be assessed through Discharge or Day 14 whichever comes first.
The tertiary objectives are to determine whether pexelizumab treatment in patients with acute STEMI expected to undergo primary PCI reduces: • composite endpoint of death, cardiogenic shock or CHF through Day 90; • composite endpoint of cardiogenic shock or CHF through Day 90; • composite endpoint of death or cardiogenic shock through Day 90; • composite endpoint of death or CHF through Day 90; • stroke through Day 90; • recurrent MI through Day 90. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Be at least 18 years of age. 2. Has experienced continuous ischemic (cardiac) symptoms for at least 20 minutes. 3. Has onset of symptoms of qualifying acute MI within the past 6 hours, and is expected to undergo primary PCI. 4. Has an ECG indicative of an acute STEMI showing: • At least 2 mm ST elevation in 2 anterior or lateral leads; or • At least 2 mm ST elevation in 2 inferior leads coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of at least 8 mm; or • new left bundle branch block with at least 1 mm concordant ST elevation. 5. Be willing to provide informed consent (informed consent may be provided by a legally authorized representative if the patient is not able to provide it). 6. Be willing and able to be followed for at least 12 months for evaluation.
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E.4 | Principal exclusion criteria |
1. Has isolated inferior wall MI without anterior ST depression (e.g. ST elevation only in II, III, AVF) 2. Has received fibrinolytic therapy for treatment of the qualifying acute STEMI. 3. Has a known or suspected hereditary complement deficiency. 4. Has presence of or suspected active neisserial infection. 5. Has evidence of a serious, active infection in the opinion of the Investigator 6. Is currently receiving or is planning to receive any other investigational drug/device during this study or has been exposed to an unapproved investigational agent within the past 30 days. 7. Is pregnant or breast-feeding. 8. Has any other serious medical condition that, in the opinion of the Investigator is likely to alter the patient’s course of recovery or the evaluation of the study medication’s safety. 9. Has previously been enrolled in this trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of all-cause mortality at Day 90 in patients with acute ST elevation myocardial infarction (STEMI) who were expected to undergo primary percutaneous coronary intervention (PCI). |
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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 | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |