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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00091637
Recruitment Status : Completed
First Posted : September 16, 2004
Last Update Posted : August 5, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Pexelizumab Drug: Placebo infusion Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5745 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: APEX-AMI - Pexelizumab in Conjunction With Angioplasty
Study Start Date : April 2004
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reduction of all causes of mortality [ Time Frame: day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091637

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

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

Responsible Party: Thomas G Todaro, MD, JD, FACC, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00091637     History of Changes
Other Study ID Numbers: 2003056
First Posted: September 16, 2004    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases