A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients with Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention - APEX-AMI

Conditions: 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: 7.0Level: LLTClassification code 10000891

Registration Number: EUCTR2004-000142-20-CZ

Lead Sponsor: Procter & Gamble Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 8500

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

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.