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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
Sponsor:
Information provided by:
Procter and Gamble

Tracking Information
First Submitted Date  ICMJE September 14, 2004
First Posted Date  ICMJE September 16, 2004
Last Update Posted Date August 5, 2011
Study Start Date  ICMJE April 2004
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
Reduction of all causes of mortality [ Time Frame: day 30 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Reduction of all causes of morality
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)
Official Title  ICMJE APEX-AMI - Pexelizumab in Conjunction With Angioplasty
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE
  • Drug: Pexelizumab
    Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once
  • Drug: Placebo infusion
    bolus infusion over a 10 minute period once
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo infusion
    Intervention: Drug: Placebo infusion
  • Experimental: 2
    Pexelizumab infusion
    Intervention: Drug: Pexelizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2008)
5745
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Netherlands,   New Zealand,   Poland,   Portugal,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00091637
Other Study ID Numbers  ICMJE 2003056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas G Todaro, MD, JD, FACC, Procter and Gamble Pharmaceuticals
Study Sponsor  ICMJE Procter and Gamble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas G Todaro, MD, JD, FACC Procter and Gamble
PRS Account Procter and Gamble
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP