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New drug aims to protect hearts after attack

NCT ID NCT03470441

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called FDY-5301 in 120 people having a severe heart attack (STEMI). Participants received either the drug or a placebo during a procedure to open blocked arteries. The main goal was to see if the drug could reduce dangerous heart rhythm problems and limit heart damage. The trial has been completed, and results will help decide if further testing is needed.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

120 people

The number who actually took part.

Started

Oct 2017

Finished

Jan 2019

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 to 80 years

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. 18-80 year old male subjects 2. 18 to 80 year old female subjects who are not of child-bearing potential. 3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads), within 12 hours of symptom onset. Written informed consent prior to study participation (either by the subject or a legally authorized representative of the subject) Exclusion Criteria: 1. Previous myocardial infarction 2. Left bundle branch block (LBBB) 3. Previous coronary artery bypass graft surgery (CABG) 4. Major hemodynamic instability or uncontrolled ventricular arrhythmias 5. Known contraindication to CMR 6. Patients with known thyroid disease 7. Subjects with past or current renal impairment requiring dialysis 8. Pregnant or females of child bearing potential 9. Body weight \> 120 kg or Body Mass Index (BMI) \> 35 kg/m2 10. Use of investigational drugs or devices within 30 days prior to enrollment into the study. 11. Life expectancy of less than 1 year due to non-cardiac pathology 12. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study

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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 STEMI

Contacts and locations

Locations

  • Borsod-Abaúj-Zemplén Megyei Központi Kórház

    Miskolc, Hungary

  • Budai Irgalmasrendi Kórház

    Budapest, Hungary

  • Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika

    Debrecen, Hungary

  • Freeman Hospital

    Newcastle upon Tyne, Tyne and Wear, United Kingdom

  • Glenfield Hospital

    Leicester, Leicestershire, United Kingdom

  • Golden Jubilee National Hospital

    Glasgow, United Kingdom

  • KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny

    Wroclaw, Poland

  • Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz, Poland

  • Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, Poland

  • Magyar Honvédség Egészségügyi Központ

    Budapest, Hungary

  • Miedziowe Centrum Zdrowia

    Lubin, Poland

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55047, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • New Cross Hospital

    Wolverhampton, West Midlands, United Kingdom

  • Ninewells Hospital and Medical School

    Dundee, United Kingdom

  • Royal Devon and Exeter Hospital Cardiology Department

    Exeter, Devon, United Kingdom

  • Royal Infirmary of Edinburgh

    Edinburgh, United Kingdom

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej

    Grodzisk Mazowiecki, Poland

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej

    Krakow, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii

    Katowice, Silesian Voivodeship, Poland

  • University of Oxford

    Oxford, Oxfordshire, United Kingdom

  • Wythenshawe Hospital

    Manchester, Greater Manchester, United Kingdom

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, Hungary

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