Galilee Medical Center | Department of Nephrology and Hypertension
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About
To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.
Full 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.
Enrollment
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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
Electrocardiogram (ECG) criteria:
Planned primary PCI to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction
Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
2,351 participants in 2 patient groups, including a placebo group
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Central trial contact
Catherine Hutt
Data sourced from clinicaltrials.gov
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