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

This study has been completed.
Information provided by:
Procter and Gamble Identifier:
First received: September 14, 2004
Last updated: August 4, 2011
Last verified: August 2011
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.

Condition Intervention Phase
Acute Myocardial Infarction
Drug: Pexelizumab
Drug: Placebo infusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: APEX-AMI - Pexelizumab in Conjunction With Angioplasty

Resource links provided by NLM:

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Reduction of all causes of mortality [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Enrollment: 5745
Study Start Date: April 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo infusion
Drug: Placebo infusion
bolus infusion over a 10 minute period once
Experimental: 2
Pexelizumab infusion
Drug: Pexelizumab
Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00091637

  Show 349 Study Locations
Sponsors and Collaborators
Procter and Gamble
Study Director: Thomas G Todaro, MD, JD, FACC Procter and Gamble
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Thomas G Todaro, MD, JD, FACC, Procter and Gamble Pharmaceuticals Identifier: NCT00091637     History of Changes
Other Study ID Numbers: 2003056 
Study First Received: September 14, 2004
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on May 26, 2016