Evaluation in STEMI Patients Using FDY-5301

Phase 3

Completed

• Conditions: STEMI; Percutaneous Coronary Revascularization; Acute Myocardial Infarction
• Interventions: Drug: FDY-5301; Other: Placebo

• Registration Number: NCT04837001
• Lead Sponsor: Faraday Pharmaceuticals, Inc.

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.

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Study Start: 2022-05-02
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FDY-5301	FDY-5301	FDY-5301 will be administered as a single IV bolus injection.
Placebo	Placebo	Placebo (normal saline) will be administered as a single IV bolus injection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (52)

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

University of Florida Health; 🇺🇸 Jacksonville, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Sparrow Clinical Research Institute; 🇺🇸 Lansing, Michigan, United States

Allina Health System; 🇺🇸 Minneapolis, Minnesota, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

Southlake Regional Health Center; 🇨🇦 Newmarket, Ontario, Canada

Budai Irgalmasrendi Kórház; 🇭🇺 Budapest, Hungary

Gottsegen György Országos Kardiológiai Intézet; 🇭🇺 Budapest, Hungary

Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály; 🇭🇺 Budapest, Hungary

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