Acute Myocardial Infarction, Percutaneous Coronary Revascularization, STEMI
Conditions
Brief summary
To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of FDY-5301 compared to placebo on cardiovascular clinical outcomes in subjects with an anterior ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). The study is designed as a randomized double-blind parallel-group comparison of FDY-5301 and placebo. Inclusion and exclusion criteria have been designed to ensure a broad population including seriously ill patients, with or without prior myocardial infarction or coronary artery bypass graft. Demonstration of efficacy in the anterior STEMI population will translate to all STEMIs agnostic of anatomical location, as the pathophysiology and pharmacology are highly likely to translate from anterior STEMIs to non-anterior STEMIs.
Interventions
DRUGFDY-5301
FDY-5301 will be administered as a single IV bolus injection.
OTHERPlacebo
Placebo will be administered as a single bolus injection.
Sponsors
Faraday Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ≤ 40 years: ≥ 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 ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction 4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation
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 | Description |
|---|---|---|
| Proportion of either cardiovascular mortality or heart failure | Through Month 12 | The proportion of subjects who experience either cardiovascular mortality or a heart failure event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality or acute heart failure | Through Month 12 | The proportion of subjects who experience either all-cause mortality or a heart failure event |
| Cardiovascular events | Through Month 12 | The total number of cardiovascular events defined as cardiovascular mortality and heart failure events |
| Other non-fatal cardiovascular morbidity | Through Month 12 | The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: 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) |
| Serum troponin T | Day 3 | Serum troponin T |
Countries
Canada, Hungary, Israel, Poland, Portugal, United States
Outcome results
None listed