We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00091637
First Posted: September 16, 2004
Last Update Posted: August 5, 2011
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.
Information provided by:
Procter and Gamble
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
Investigators
Study Director: Thomas G Todaro, MD, JD, FACC Procter and Gamble
  More Information

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 Submitted: September 14, 2004
First Posted: September 16, 2004
Last Update Posted: August 5, 2011
Last Verified: August 2011

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