To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,351
Proportion of either cardiovascular mortality or heart failure
The proportion of subjects who experience either cardiovascular mortality or a heart failure event
Time frame: Through Month 12
All-cause mortality or acute heart failure
The proportion of subjects who experience either all-cause mortality or a heart failure event
Time frame: Through Month 12
Cardiovascular events
The total number of cardiovascular events defined as cardiovascular mortality and heart failure events
Time frame: Through Month 12
Other non-fatal cardiovascular morbidity
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)
Time frame: Through Month 12
Serum troponin T
Serum troponin T
Time frame: Day 3
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