NCT04837001

Evaluation in STEMI Patients Using FDY-5301

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,351 (actual)
• Sponsor: Faraday Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myocardial Infarction
• STEMI
• Percutaneous Coronary Revascularization

Interventions

Type	Name	Description
DRUG	FDY-5301	FDY-5301 will be administered as a single IV bolus injection.
OTHER	Placebo	Placebo will be administered as a single bolus injection.

Timeline

• Start date: 2022-05-02
• Primary completion: 2025-09-03
• Completion: 2025-09-03
• First posted: 2021-04-08
• Last updated: 2025-09-12

Locations

52 sites across 6 countries: United States, Canada, Hungary, Israel, Poland, Portugal

Regulatory

• FDA-regulated drug study