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

Procter & Gamble (P&G)

Status and phase: Completed; Phase 3

Conditions: Acute Myocardial Infarction

Treatments: Drug: Placebo infusion; Drug: Pexelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091637

2003056

Details and patient eligibility

About

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.

Enrollment: 5,745 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5,745 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo infusion

Treatment:

Drug: Placebo infusion

2

Experimental group

Description:

Pexelizumab infusion

Treatment:

Drug: Pexelizumab