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Acute Myocardial InfarctionPhase 3IOCYTE AMI-3NCT04837001

Evaluation in STEMI Patients Using FDY-5301

A Phase 3 study testing FDY-5301 in people with Acute Myocardial Infarction and STEMI, run by Faraday Pharmaceuticals, Inc. at 52 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FDY-5301
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,351 participants
Where
52 sitesin 6 countries
Study dates
2 May 2022to 3 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

52 sites in 6 countries.

52 sites in 6 countries

Poland15 sites

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, 15-276

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

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

    Grodzisk Mazowiecki, 05-825

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • Center for Invasive Cardiology

    Krosno, 38-400

  • Scanmed Centrum Kardiologii Kutno

    Kutno, 99-300

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej

    Lodz, 90-549

  • Central Clinical Hospital of the Medical University of Łódź

    Lodz, 92-213

  • Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

    Lublin, 20-049

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Torun, 87-100

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-556

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50-981

  • Provincial Specialist Hospital in Wrocław

    Wroclaw, 51-124

  • Independent Public Provincial Hospital

    Zamość, 22-400

Other trials in Poland

Hungary13 sites

  • Budai Irgalmasrendi Kórház

    Budapest, 1023

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096

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

    Budapest, 1106

  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122

  • Észak-Pesti Centrumkórház - Honvédkórház

    Budapest, 1134

  • Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály

    Kaposvár, 7400

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc, 3526

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

    Nyíregyháza, 4400

  • Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika

    Pécs, 7624

  • Fejér Vármegyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000

  • Vas Vármegyei Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Israel10 sites

  • Shamir (Assaf Harofeh) Medical Center

    Be’er Ya‘aqov, 7033001

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Ein Karem Medical Center

    Jerusalem, 9112001

  • Shaare Zedek Medical Center

    Jerusalem, 91301

  • Meir Medical Center

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 4941492

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Ziv Medical Center

    Safed, 13110

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Portugal7 sites

  • Hospital Garcia da Orta

    Almada, Setúbal District, 2805-267

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitário de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar Universitário Lisboa Central

    Lisbon, 1169-024

  • Centro Hospitalar Universitário Lisboa Norte

    Lisbon, 1649-035

  • Centro Hospitalar Universitário do Porto

    Porto, 4099-001

  • Centro Hospitalar Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

United States6 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Florida Health

    Jacksonville, Florida, 32209

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Allina Health System

    Minneapolis, Minnesota, 55407

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

Other trials in United States

Canada1 site

  • Southlake Regional Health Center

    Newmarket, Ontario, L3Y 2P9

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
FDY-5301, Placebo
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDY-5301Drug

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

  • PlaceboOther

    Placebo will be administered as a single bolus injection.

Study groups in NCT04837001
Study groupRoleWhat they receive
FDY-5301ExperimentalFDY-5301 will be administered as a single IV bolus injection.
Receives: Drug: FDY-5301
PlaceboPlacebo comparatorPlacebo (normal saline) will be administered as a single IV bolus injection.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of either cardiovascular mortality or heart failure

    The proportion of subjects who experience either cardiovascular mortality or a heart failure event

    Measured: Through Month 12

Secondary outcomes (4)

  1. All-cause mortality or acute heart failure

    The proportion of subjects who experience either all-cause mortality or a heart failure event

    Measured: Through Month 12

  2. Cardiovascular events

    The total number of cardiovascular events defined as cardiovascular mortality and heart failure events

    Measured: Through Month 12

  3. 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)

    Measured: Through Month 12

  4. Serum troponin T

    Serum troponin T

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start2 May 2022
  3. Primary completion3 Sep 2025
  4. Study completion3 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All subjects who fulfill all study eligibility criteria will be randomized and dosed with study drug or placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837001
Sponsor's protocol ID
FDY-5301-302
Other IDs
2021-001924-16
Acronym
IOCYTE AMI-3
Status last verified
Sep 2025
First submitted
6 Apr 2021
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FDY-5301 in people with Acute Myocardial Infarction and STEMI, run by Faraday Pharmaceuticals, Inc. at 52 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Poland, Hungary, Israel, Portugal, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of either cardiovascular mortality or heart failure (time frame: Through Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04837001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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