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

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00091637
First received: September 14, 2004
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091637

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

No publications provided by Procter and Gamble

Additional 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
Study First Received: September 14, 2004
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014