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New shot aims to save hearts after major attack

NCT ID NCT04837001

Disease control Sponsor: Faraday Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a single injection of FDY 5301 in over 2,300 people who had a severe type of heart attack (anterior STEMI) and were getting emergency artery-opening treatment. The goal was to see if the drug could lower the chance of dying or developing heart failure within a few months. The trial is complete, but results have not been shared yet.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FDY 5301 (a single intravenous injection)
What this could lead to
If it works, this could reduce the risk of dying or developing heart failure after a major heart attack.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. The drug may not show a clear benefit over placebo, and any new treatment carries unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2,351 people

The number who actually took part.

Started

May 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myocardial infarction Percutaneous coronary revascularization STEMI

Contacts and locations

Locations

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, 50-981, Poland

  • Allina Health System

    Minneapolis, Minnesota, 55407, United States

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

    Budapest, 1106, Hungary

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

    Miskolc, 3526, Hungary

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Budai Irgalmasrendi Kórház

    Budapest, 1023, Hungary

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000, Hungary

  • Center for Invasive Cardiology

    Krosno, 38-400, Poland

  • Central Clinical Hospital of the Medical University of Łódź

    Lodz, 92-213, Poland

  • Centro Hospitalar Universitário Lisboa Central

    Lisbon, 1169-024, Portugal

  • Centro Hospitalar Universitário Lisboa Norte

    Lisbon, 1649-035, Portugal

  • Centro Hospitalar Universitário do Porto

    Porto, 4099-001, Portugal

  • Centro Hospitalar Vila Nova de Gaia/Espinho

    Vila Nova de Gaia, 4434-502, Portugal

  • Centro Hospitalar e Universitário de Coimbra

    Coimbra, 3000-075, Portugal

  • Fejér Vármegyei Szent György Egyetemi Oktató Kórház

    Székesfehérvár, 8000, Hungary

  • Galilee Medical Center

    Nahariya, 2210001, Israel

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096, Hungary

  • Hadassah Ein Karem Medical Center

    Jerusalem, 9112001, Israel

  • Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Hospital Garcia da Orta

    Almada, Setúbal District, 2805-267, Portugal

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Independent Public Provincial Hospital

    Zamość, 22-400, Poland

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

    Grodzisk Mazowiecki, 05-825, Poland

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Provincial Specialist Hospital in Wrocław

    Wroclaw, 51-124, Poland

  • Pécsi Tudományegyetem Klinikai Kozpönt Szívgyógyászati Klinika

    Pécs, 7624, Hungary

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688, Poland

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954, Poland

  • Scanmed Centrum Kardiologii Kutno

    Kutno, 99-300, Poland

  • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122, Hungary

  • Shaare Zedek Medical Center

    Jerusalem, 91301, Israel

  • Shamir (Assaf Harofeh) Medical Center

    Be’er Ya‘aqov, 7033001, Israel

  • Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Somogy Vármegyei Kaposi Mór Oktató Kórház, Kardiológiai Osztály

    Kaposvár, 7400, Hungary

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Southlake Regional Health Center

    Newmarket, Ontario, L3Y 2P9, Canada

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

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

    Nyíregyháza, 4400, Hungary

  • University of Florida Health

    Jacksonville, Florida, 32209, United States

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

    Wroclaw, 50-556, Poland

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej

    Lodz, 90-549, Poland

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, 15-276, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Vas Vármegyei Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700, Hungary

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Torun, 87-100, Poland

  • Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie

    Lublin, 20-049, Poland

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, 8900, Hungary

  • Ziv Medical Center

    Safed, 13110, Israel

  • Észak-Pesti Centrumkórház - Honvédkórház

    Budapest, 1134, Hungary

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Other studies related to the condition(s) this trial covers.