myocardial infarction STEMI
Conditions
Interventions
FDY-5301 (2 mg/kg) will be administered as a single IV bolus injection or
Placebo (normal saline) will be administered as a single IV bolus injection.
Placebo will be volume-matched and indistinguis
Sponsors
Faraday Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years 2. 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 Electrocardiogram (ECG) criteria: • men > 40 years: >= 2 mm of ST elevation in V2 and V3 • men = 2.5 mm of ST elevation in V2 and V3 • women >= 1.5 mm of ST elevation in V2 and V3 3. Planned primary PCI to occur
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 1 year due to non-cardiac pathology 2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization 3. Known allergy to iodine or the excipient of the investigational product (sodium chloride) 4. Renal disease requiring dialysis 5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization 6. Body weight >140 kg (or 309 lbs) 7. Use of thrombolytic therapy as treatment for the index STEMI event 8. Use of investigational drugs within 30 days or 5 half-lives whichever is longer, prior to randomization or the use of investigational devices within 30 days prior to randomization 9. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who experience either cardiovascular mortality (defined as deaths which are sudden and due to presumed arrhythmia, or deaths due to presumed or confirmed thromboembolic cerebral vascular accident, presumed or confirmed pulmonary embolism, cardiac rupture, heart failure, recurrent myocardial infarction [e.g., remote or stent thrombosis], and deaths due to procedural efforts to treat these defined cardiac events), or a heart failure event through Month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: - The proportion of subjects who experience either all-cause mortality or a heart failure event through Month 12 - The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through Month 12 - The proportion of subjects who experience a composite the following specified non-fatal cardiovascular events of thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia requiring intervention (e.g., ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia requiring intervention) through Month 12 - Serum troponin T at Day 3 Exploratory Endpoints: Individual adverse cardiovascular event outcomes will be evaluated as follows: - Non-fatal thromboembolic CVA through Month 12 - Non-fatal ventricular aneurysm/hemorrhage through Month 12 - Non-fatal recurrent myocardial infarction (e.g., remote or stent thrombosis) through Month 12 - Persistent requiring intervention (e.g., ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia requiring intervention) arrhythmia through Month 12 - Heart failure managed with initiation or intensification of oral treatment through Month 12 - The proportion of subjects who experience all-cause mortality through Month 12 | — |
Countries
Netherlands
Outcome results
None listed