Evaluation in STEMI Patients Using FDY-5301

Inclusion Criteria:

Age ≥ 18 years

Anterior STEMI, based on:

Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and

ECG criteria:

men > 40 years: ≥ 2 mm of ST elevation in V2 and V3
men ≤ 40 years: ≥ 2.5 mm of ST elevation in V2 and V3
women ≥ 1.5 mm of ST elevation in V2 and V3
Planned primary PCI to occur ≤ 6 hours of onset of first symptoms of myocardial ischemia
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation

Exclusion Criteria:

Life expectancy of less than 1 year due to non-cardiac pathology
Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
Known allergy to iodine
Renal disease requiring dialysis
Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
Body weight > 140 kg (or 309 lbs)
Use of thrombolytic therapy as treatment for the index STEMI event
Use of investigational drugs or devices 30 days prior to randomization
Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301