Evaluation in STEMI Patients Using FDY-5301

Acute Myocardial Infarction Clinical Trial

— IOCYTE AMI-3  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04837001
• Other study ID #: FDY-5301-302
• Secondary ID: 2021-001924-16
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 2, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Faraday Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2351
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Percutaneous Coronary Revascularization
• STEMI

Intervention

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.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Center	Newmarket	Ontario
Hungary	Bajcsy-Zsilinszky Kórház és Rendelointézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály	Budapest
Hungary	Budai Irgalmasrendi Kórház	Budapest
Hungary	Észak-Pesti Centrumkórház - Honvédkórház	Budapest
Hungary	Gottsegen György Országos Kardiológiai Intézet	Budapest
Hungary	Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika	Budapest
Hungary	Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály	Kaposvár
Hungary	Bács-Kiskun Vármegyei Oktatókórház	Kecskemét
Hungary	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház	Miskolc
Hungary	Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház	Nyíregyháza
Hungary	Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika	Pécs
Hungary	Fejér Vármegyei Szent György Egyetemi Oktató Kórház	Székesfehérvár
Hungary	Vas Vármegyei Markusovszky Egyetemi Oktatókórház	Szombathely
Hungary	Zala Megyei Szent Rafael Kórház	Zalaegerszeg
Israel	Shamir (Assaf Harofeh) Medical Center	Be'er Ya'aqov
Israel	Rambam Health Care Campus	Haifa
Israel	Hadassah Ein Karem Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Galilee Medical Center	Nahariya
Israel	Rabin Medical Center, Beilinson Hospital	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Ziv Medical Center	Safed
Israel	Sourasky Medical Center	Tel Aviv
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Independent Public Specialist Hospital of the West st. John Paul II	Grodzisk Mazowiecki
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie	Kraków
Poland	Center for Invasive Cardiology	Krosno
Poland	Scanmed Centrum Kardiologii Kutno	Kutno
Poland	Central Clinical Hospital of the Medical University of Lódz	Lódz
Poland	Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej	Lódz
Poland	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin
Poland	Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie	Lublin
Poland	Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu	Torun
Poland	4. Military Clinical Hospital with Polyclinic SP ZOZ	Wroclaw
Poland	Provincial Specialist Hospital in Wroclaw	Wroclaw
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Poland	Independent Public Provincial Hospital	Zamosc
Portugal	Hospital Garcia da Orta	Almada	Setubal
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar e Universitário de Coimbra	Coimbra
Portugal	Centro Hospitalar Universitário Lisboa Central	Lisboa
Portugal	Centro Hospitalar Universitário Lisboa Norte	Lisboa
Portugal	Centro Hospitalar Universitário do Porto	Porto
Portugal	Centro Hospitalar Vila Nova de Gaia/Espinho	Vila Nova De Gaia
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Florida Health	Jacksonville	Florida
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Allina Health System	Minneapolis	Minnesota
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Faraday Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Israel,  Poland,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cardiovascular events	The total number of cardiovascular events defined as cardiovascular mortality and heart failure events	Through Month 12
Secondary	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
Secondary	Serum troponin T	Serum troponin T	Day 3