Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)
Recruiting in Palo Alto (17 mi)
+373 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Procter and Gamble
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility 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;
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Treatment Details
Interventions
- Pexelizumab (Complement Inhibitor)
- Placebo infusion (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment1 Intervention
Pexelizumab infusion
Group II: 1Placebo Group1 Intervention
Placebo infusion
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Pittsburgh Healthcare SystemPittsburgh, PA
Providence Holy Cross Medical CenterValencia, CA
University of Connecticut Health CenterFarmington, CT
Foothills Medical CentreCalgary, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Procter and GambleLead Sponsor