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

NCT00091637 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5745

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Pexelizumab

Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once

DRUG

Placebo infusion

bolus infusion over a 10 minute period once

Sponsors & Collaborators

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Thomas G Todaro, MD, JD, FACC · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Spain
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00091637 on ClinicalTrials.gov