Evaluation in STEMI Patients Using FDY-5301

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY 5301 in Patients With an Anterior ST-Elevation Myocardial Infarction

Conditions
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Acute Myocardial Infarction, STEMI, Percutaneous Coronary Revascularization

Intervention / Treatment
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* Drug: FDY-5301
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDY-5301<br>FDY-5301 will be administered as a single IV bolus injection. | Drug: FDY-5301<br>* FDY-5301 will be administered as a single IV bolus injection.<br>|
| Placebo Comparator: Placebo<br>Placebo (normal saline) will be administered as a single IV bolus injection. | Other: Placebo<br>* Placebo will be administered as a single bolus injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of either cardiovascular mortality or acute heart failure | The proportion of subjects who experience either cardiovascular mortality or an acute heart failure event | Through Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality or acute heart failure | The proportion of subjects who experience either all-cause mortality or an acute heart failure event | Through Month 12 | 
| Cardiovascular events | The total number of cardiovascular events defined as cardiovascular mortality and acute heart failure events | Through Month 12 | 
| Other non-fatal cardiovascular morbidity | The proportion of subjects who experience other non-fatal cardiovascular morbidity such as CVA, ventricular aneurysm/hemorrhage, recurrent myocardial infarction, or persistent arrhythmia | Through Month 12 | 
| Serum troponin T | Serum troponin T | Day 3 |