A Study of Acute Myocardial Infarction Using FDY-5301

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Myocardial Infarction, STEMI

In brief

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of three dose levels of FDY-5301 compared to placebo in STEMI patients undergoing PCI.

Key facts

Study ID

NCT03470441

Run by

Faraday Pharmaceuticals, Inc.

People needed

120

Starts

2017-10-27

Expected to finish

2019-01-03

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-80 year old male subjects
• 18 to 80 year old female subjects who are not of child-bearing potential.
• 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)

You may not qualify if…

• Previous myocardial infarction
• Left bundle branch block (LBBB)
• Previous coronary artery bypass graft surgery (CABG)
• Major hemodynamic instability or uncontrolled ventricular arrhythmias
• Known contraindication to CMR
• Patients with known thyroid disease
• Subjects with past or current renal impairment requiring dialysis
• Pregnant or females of child bearing potential
• Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
• Use of investigational drugs or devices within 30 days prior to enrollment into the study.
• Life expectancy of less than 1 year due to non-cardiac pathology
• 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

Where it is running

• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Budai Irgalmasrendi Kórház — Budapest, Hungary
• Magyar Honvédség Egészségügyi Központ — Budapest, Hungary
• Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika — Debrecen, Hungary
• Borsod-Abaúj-Zemplén Megyei Központi Kórház — Miskolc, Hungary
• Zala Megyei Szent Rafael Kórház — Zalaegerszeg, Hungary
• 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
• 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
• Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi — Lodz, Poland
• Miedziowe Centrum Zdrowia — Lubin, Poland
• Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie — Warsaw, Poland
• KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny — Wroclaw, Poland
• Royal Devon and Exeter Hospital Cardiology Department — Exeter, Devon, United Kingdom
• Wythenshawe Hospital — Manchester, Greater Manchester, United Kingdom
• Glenfield Hospital — Leicester, Leicestershire, United Kingdom
• University of Oxford — Oxford, Oxfordshire, United Kingdom
• Freeman Hospital — Newcastle upon Tyne, Tyne and Wear, United Kingdom
• New Cross Hospital — Wolverhampton, West Midlands, United Kingdom
• Ninewells Hospital and Medical School — Dundee, United Kingdom
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom
• Golden Jubilee National Hospital — Glasgow, United Kingdom

Full record on ClinicalTrials.gov

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