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. MedDRA version: 7.0 Level: LLT Classification code 10000891
Conditions
Interventions
Product Name: pexelizumab
Product Code: h5G1.1-scFv
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intra
Sponsors
Procter & Gamble Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
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 ? 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. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: 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.;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). | — |
Countries
Czech Republic, Italy, Spain, Sweden
Outcome results
None listed