Evaluation in STEMI Patients Using FDY-5301 (IOCYTE AMI-3)

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

To assess the effect of FDY-5301 on cardiovascular mortality and acute heart failure events in subjects with an anterior STEMI undergoing pPCI.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction; STEMI; Percutaneous Coronary Revascularization
• Intervention / Treatment: Drug: FDY-5301; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 2351
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Center
• Hungary
  • Budapest, Hungary, 1096
    • Gottsegen György Országos Kardiológiai Intézet
  • Budapest, Hungary, 1023
    • Budai Irgalmasrendi Kórház
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
  • Budapest, Hungary, 1134
    • Észak-Pesti Centrumkórház - Honvédkórház
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály
  • Kaposvár, Hungary, 7400
    • Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály
  • Kecskemét, Hungary, 6000
    • Bács-Kiskun Vármegyei Oktatókórház
  • Miskolc, Hungary, 3526
    • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház
  • Nyíregyháza, Hungary, 4400
    • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház
  • Pécs, Hungary, 7624
    • Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika
  • Szombathely, Hungary, 9700
    • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
  • Székesfehérvár, Hungary, 8000
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Zalaegerszeg, Hungary, 8900
    • Zala Megyei Szent Rafael Korhaz
• Israel
  • Be’er Ya‘aqov, Israel, 7033001
    • Shamir (Assaf Harofeh) Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Hadassah Ein Karem Medical Center
  • Jerusalem, Israel, 91301
    • Shaare Zedek Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center, Beilinson Hospital
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center
  • Safed, Israel, 13110
    • Ziv Medical Center
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center
• Poland
  • Bialystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny W Białymstoku
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Grodzisk Mazowiecki, Poland, 05-825
    • Independent Public Specialist Hospital of the West st. John Paul II
  • Krakow, Poland, 30-688
    • Sp Zoz Szpital Uniwersytecki W Krakowie
  • Krosno, Poland, 38-400
    • Center for Invasive Cardiology
  • Kutno, Poland, 99-300
    • Scanmed Centrum Kardiologii Kutno
  • Lodz, Poland, 90-549
    • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej
  • Lodz, Poland, 92-213
    • Central Clinical Hospital of the Medical University of Łódź
  • Lublin, Poland, 20-954
    • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Lublin, Poland, 20-049
    • Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
  • Torun, Poland, 87-100
    • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
  • Wroclaw, Poland, 50-981
    • 4. Military Clinical Hospital with Polyclinic SP ZOZ
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Wroclaw, Poland, 51-124
    • Provincial Specialist Hospital in Wrocław
  • Zamość, Poland, 22-400
    • Independent Public Provincial Hospital
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitario de Coimbra
  • Lisbon, Portugal, 1169-024
    • Centro Hospitalar Universitário Lisboa Central
  • Lisbon, Portugal, 1649-035
    • Centro Hospitalar Universitario Lisboa Norte
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar Vila Nova de Gaia/Espinho
  • Setúbal District
    • Almada, Setúbal District, Portugal, 2805-267
      • Hospital Garcia da Orta
• United States
  • California
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health System
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum troponin T	Serum troponin T	Day 3
All-cause mortality or acute heart failure	The proportion of subjects who experience either all-cause mortality or a heart failure event	Through Month 12
Cardiovascular events	The total number of cardiovascular events defined as cardiovascular mortality and heart failure events	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)	Through Month 12

Collaborators and Investigators

• Sponsor: Faraday Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: FDY-5301-302; 2021-001924-16 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No