Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Procter and Gamble

Criteria

Inclusion Criteria:

• Cardiac symptoms for at least 20 minutes within past 6 hours;

• Will undergo primary PCI;

• Has ECG evidence of acute high risk ST elevation myocardial infarction;

• Willing and able to be followed for at least 12 months.

Exclusion Criteria:

• Isolated low risk inferior wall myocardial infarction;

• Received fibrinolytic therapy;

• History of complement deficiency;

• Suspected neisserial infection;

• Participating in other investigational study;

• Pregnancy;

• Previous enrollment.