The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a percutaneous coronary intervention (PCI). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,180
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
Time frame: During the index hospitalization
The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Time frame: Within the first 3 months after Myocardial Infarction
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Time frame: Within the first 3 months after Myocardial Infarction
Assess left ventricular function by imaging
Time frame: Within the first 3 months after Myocardial Infarction
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Huntsville, Alabama, United States
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Escondido, California, United States
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Torrance, California, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Downers Grove, Illinois, United States
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Lombard, Illinois, United States
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Peoria, Illinois, United States
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Valparaiso, Indiana, United States
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Omaha, Nebraska, United States
...and 116 more locations