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: Recruiting
• 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 (Estimated): 2300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Catherine Hutt; Phone Number: 206-492-5310; Email: IOCYTEAMI3@FaradayPharma.com

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Recruiting
      • Southlake Regional Health Center
• Hungary
  • Budapest, Hungary, 1096
    • Recruiting
    • Gottsegen György Országos Kardiológiai Intézet
  • Budapest, Hungary, 1023
    • Recruiting
    • Budai Irgalmasrendi Korhaz
  • Budapest, Hungary, 1106
    • Recruiting
    • Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály
  • Budapest, Hungary, 1122
    • Recruiting
    • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
  • Budapest, Hungary, 1134
    • Recruiting
    • Eszak-Pesti Centrumkorhaz - Honvedkorhaz
  • Miskolc, Hungary, 3526
    • Recruiting
    • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
  • Nyíregyháza, Hungary, 4400
    • Recruiting
    • Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház
  • Pécs, Hungary, 7624
    • Recruiting
    • Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika
  • Szombathely, Hungary, 9700
    • Recruiting
    • Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
  • Székesfehérvár, Hungary, 8000
    • Recruiting
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Zalaegerszeg, Hungary, 8900
    • Recruiting
    • Zala Megyei Szent Rafael Kórház
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Ein Karem Medical Center
  • Jerusalem, Israel, 91301
    • Recruiting
    • Shaare Zedek Medical Center
  • Kfar Saba, Israel, 4428164
    • Recruiting
    • Meir Medical Center
  • Nahariya, Israel, 2210001
    • Recruiting
    • Galilee Medical Center
  • Petach Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center, Beilinson Hospital
  • Ramat Gan, Israel, 5265601
    • Recruiting
    • Sheba Medical Center
  • Safed, Israel, 13110
    • Recruiting
    • Ziv Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Sourasky Medical Center
• Poland
  • Białystok, Poland, 15-276
    • Recruiting
    • Uniwersytecki Szpital Kliniczny w Białymstoku
  • Gdańsk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Grodzisk Mazowiecki, Poland, 05-825
    • Recruiting
    • Independent Public Specialist Hospital of the West st. John Paul II
  • Kraków, Poland, 30-688
    • Recruiting
    • Sp Zoz Szpital Uniwersytecki W Krakowie
  • Krosno, Poland, 38-400
    • Recruiting
    • Center for Invasive Cardiology
  • Kutno, Poland, 99-300
    • Recruiting
    • Scanmed Centrum Kardiologii Kutno
  • Lublin, Poland, 20-954
    • Recruiting
    • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
  • Lublin, Poland, 20-049
    • Recruiting
    • Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
  • Toruń, Poland, 87-100
    • Recruiting
    • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
  • Warszawa, Poland, 02-507
    • Withdrawn
    • Centralny Szpital Kliniczny MSWiA w Warszawie, Klinika Kardiologii Inwazyjnej
  • Wrocław, Poland, 50-556
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Wrocław, Poland, 50-981
    • Recruiting
    • 4. Military Clinical Hospital with Polyclinic SP ZOZ
  • Wrocław, Poland, 51-124
    • Recruiting
    • Provincial Specialist Hospital in Wrocław
  • Zamość, Poland, 22-400
    • Recruiting
    • Independent Public Provincial Hospital
  • Łódź, Poland, 92-213
    • Recruiting
    • Central Clinical Hospital of the Medical University of Łódź
  • Łódź, Poland, 90-549
    • Recruiting
    • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej
• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • Recruiting
    • Centro Hospitalar e Universitário de Coimbra
  • Lisboa, Portugal, 1649-035
    • Recruiting
    • Centro Hospitalar Universitário Lisboa Norte
  • Lisboa, Portugal, 1169-024
    • Recruiting
    • Centro Hospitalar Universitário Lisboa Central
  • Porto, Portugal, 4099-001
    • Recruiting
    • Centro Hospitalar Universitario do Porto
  • Vila Nova De Gaia, Portugal, 4434-502
    • Recruiting
    • Centro Hospitalar Vila Nova de Gaia/Espinho
  • Setubal
    • Almada, Setubal, Portugal, 2805-267
      • Recruiting
      • Hospital Garcia da Orta
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
  • California
    • Torrance, California, United States, 90502
      • Recruiting
      • Harbor-UCLA Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Recruiting
      • University of Florida Health
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Withdrawn
      • Emory University Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Recruiting
      • Sparrow Clinical Research Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Allina Health System
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
    • Toledo, Ohio, United States, 43608
      • Withdrawn
      • Mercy Health St. Vincent Hospital
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Withdrawn
      • Johnson City Medical Center

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

   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 first symptoms of myocardial ischemia
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
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 or devices 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 acute heart failure	The proportion of subjects who experience either cardiovascular mortality or an acute heart failure event	Through Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality or acute heart failure	The proportion of subjects who experience either all-cause mortality or an acute heart failure event	Through Month 12
Cardiovascular events	The total number of cardiovascular events defined as cardiovascular mortality and acute heart failure events	Through Month 12
Other non-fatal cardiovascular morbidity	The proportion of subjects who experience other non-fatal cardiovascular morbidity such as CVA, ventricular aneurysm/hemorrhage, recurrent myocardial infarction, or persistent arrhythmia	Through Month 12
Serum troponin T	Serum troponin T	Day 3

Collaborators and Investigators

• Sponsor: Faraday Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 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 (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• 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