Evaluation in STEMI Patients Using FDY-5301

NCT04837001 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: FDY-5301-3022021-001924-16
• Study Type: interventional
• Target: 2,351
• Locations: 6 countries
• Sites: 52

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.

Conditions

Acute Myocardial Infarction; STEMI; Percutaneous Coronary Revascularization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-cause mortality or acute heart failure

  Through Month 12

• Cardiovascular events

  Through Month 12

• Other non-fatal cardiovascular morbidity

  Through Month 12

• Serum troponin T

  Day 3

Study Arms (2)

FDY-5301

EXPERIMENTAL

FDY-5301 will be administered as a single IV bolus injection.

Drug: FDY-5301

Placebo

PLACEBO COMPARATOR

Placebo (normal saline) will be administered as a single IV bolus injection.

Other: Placebo

Interventions

FDY-5301 DRUG

FDY-5301 will be administered as a single IV bolus injection.

FDY-5301

Placebo OTHER

Placebo will be administered as a single bolus injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• 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
• Planned primary PCI to occur ≤ 6 hours of onset of persistent symptoms that caused the patient to pursue medical care for myocardial infarction
• Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation

You may not qualify if:

• Life expectancy of less than 1 year due to non-cardiac pathology
• Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization
• Known allergy to iodine or the excipient of the investigational product (sodium chloride)
• Renal disease requiring dialysis
• Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
• Body weight \> 140 kg (or 309 lbs)
• Use of thrombolytic therapy as treatment for the index STEMI event
• 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
• 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

Sponsors & Collaborators

• Faraday Pharmaceuticals, Inc.: lead

Study Sites (52)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Florida Health

Jacksonville, Florida, 32209, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48912, United States

Location

Allina Health System

Minneapolis, Minnesota, 55407, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Southlake Regional Health Center

Newmarket, Ontario, L3Y 2P9, Canada

Location

Budai Irgalmasrendi Kórház

Budapest, 1023, Hungary

Location

Gottsegen György Országos Kardiológiai Intézet

Budapest, 1096, Hungary

Location

Bajcsy-Zsilinszky Kórház és Rendelőintézet IV. Belgyógyászat és Kardiológia, Intenzív Coronaria Egység, Haemodinamikai Osztály

Budapest, 1106, Hungary

Location

Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

Budapest, 1122, Hungary

Location

Észak-Pesti Centrumkórház - Honvédkórház

Budapest, 1134, Hungary

Location

Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály

Kaposvár, 7400, Hungary

Location

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, 6000, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, 3526, Hungary

Location

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház, Nyíregyházi Jósa András Tagkórház

Nyíregyháza, 4400, Hungary

Location

Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika

Pécs, 7624, Hungary

Location

Fejér Vármegyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, 8000, Hungary

Location

Vas Vármegyei Markusovszky Egyetemi Oktatókórház

Szombathely, 9700, Hungary

Location

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, 8900, Hungary

Location

Shamir (Assaf Harofeh) Medical Center

Be’er Ya‘aqov, 7033001, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Hadassah Ein Karem Medical Center

Jerusalem, 9112001, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91301, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Galilee Medical Center

Nahariya, 2210001, Israel

Location

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Ziv Medical Center

Safed, 13110, Israel

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, 15-276, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Independent Public Specialist Hospital of the West st. John Paul II

Grodzisk Mazowiecki, 05-825, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Center for Invasive Cardiology

Krosno, 38-400, Poland

Location

Scanmed Centrum Kardiologii Kutno

Kutno, 99-300, Poland

Location

Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej

Lodz, 90-549, Poland

Location

Central Clinical Hospital of the Medical University of Łódź

Lodz, 92-213, Poland

Location

Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

Lublin, 20-049, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, 20-954, Poland

Location

Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, 87-100, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, 50-556, Poland

Location

4. Military Clinical Hospital with Polyclinic SP ZOZ

Wroclaw, 50-981, Poland

Location

Provincial Specialist Hospital in Wrocław

Wroclaw, 51-124, Poland

Location

Independent Public Provincial Hospital

Zamość, 22-400, Poland

Location

Hospital Garcia da Orta

Almada, Setúbal District, 2805-267, Portugal

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar Universitário Lisboa Central

Lisbon, 1169-024, Portugal

Location

Centro Hospitalar Universitário Lisboa Norte

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar Universitário do Porto

Porto, 4099-001, Portugal

Location

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4434-502, Portugal

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 2, 2022
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

IL (10); HU (13); PL (15); PT (7); CA (1); US (6)