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

Phase 3

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Placebo infusion; Drug: Pexelizumab

• Registration Number: NCT00091637
• Lead Sponsor: Procter and Gamble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-09-14
• Study First Submitted QC: 2004-09-15
• Study First Posted: 2004-09-16
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5745

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo infusion	Placebo infusion
2	Pexelizumab	Pexelizumab infusion

Primary Outcome Measures

Name	Time	Method
Reduction of all causes of mortality	day 30

Trial Locations

Locations (343)

Huntsville Hospital; 🇺🇸 Huntsville, Alabama, United States

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

North Phoenix Heart Center; 🇺🇸 Phoenix, Arizona, United States

Northwest Medical Center; 🇺🇸 Tucson, Arizona, United States

Sparks Regional Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Arkansas State Hospital; 🇺🇸 Little Rock, Arkansas, United States

Brotman Medical Center; 🇺🇸 Beverly Hills, California, United States

Providence Saint Joseph Medical Center; 🇺🇸 Burbank, California, United States

Palomar Medical Center; 🇺🇸 Escondido, California, United States

Los Angeles Community Hospital; 🇺🇸 Los Angeles, California, United States

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