Acute Myocardial InfarctionPhase 2NCT03470441
A Study of Acute Myocardial Infarction Using FDY-5301
A Phase 2 study testing FDY-5301 in people with Acute Myocardial Infarction and STEMI, run by Faraday Pharmaceuticals, Inc. at 23 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction, STEMI
- 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
- 120 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 27 Oct 2017to 3 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United Kingdom9 sites
Ninewells Hospital and Medical School
Dundee
Royal Infirmary of Edinburgh
Edinburgh
Royal Devon and Exeter Hospital Cardiology Department
Exeter, Devon
Golden Jubilee National Hospital
Glasgow
Glenfield Hospital
Leicester, Leicestershire
Wythenshawe Hospital
Manchester, Greater Manchester
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear
University of Oxford
Oxford, Oxfordshire
New Cross Hospital
Wolverhampton, West Midlands
Poland7 sites
Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
Grodzisk Mazowiecki
Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii
Katowice, Silesian Voivodeship
Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
Krakow
Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz
Miedziowe Centrum Zdrowia
Lubin
Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw
KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny
Wroclaw
Hungary5 sites
Budai Irgalmasrendi Kórház
Budapest
Magyar Honvédség Egészségügyi Központ
Budapest
Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika
Debrecen
Borsod-Abaúj-Zemplén Megyei Központi Kórház
Miskolc
Zala Megyei Szent Rafael Kórház
Zalaegerszeg
United States2 sites
Minneapolis Heart Institute
Minneapolis, Minnesota, 55047
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
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.
Read the detailed description
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA).
A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury".
FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug.
Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.
- Conditions
- Acute Myocardial Infarction, STEMI
- 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 once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
PlaceboOther
Also called Saline
Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
| Study group | Role | What they receive |
|---|---|---|
| FDY-5301 Low Dose | Experimental | Anticipated n=20 Receives: Drug: FDY-5301 |
| FDY-5301 Intermediate Dose | Experimental | Anticipated n=20 Receives: Drug: FDY-5301 |
| FDY-5301 High Dose | Experimental | Anticipated n=20 Receives: Drug: FDY-5301 |
| Placebo | Placebo comparator | Anticipated n=20 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmias of Interest, 48 Hours (Overall)
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Measured: First 48 hours post-treatment
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Measured: 48 hours post-treatment
Arrhythmias of Interest, 14 Days (Overall)
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
Measured: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Measured: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Secondary outcomes (15)
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
Measured: 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Measured: 3 months post-treatment
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
Measured: 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Measured: 3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
Measured: 72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Measured: 3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
Measured: 72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Measured: 3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Left ventricular ejection fraction at 72 hours post-treatment
Measured: 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Overall)
Left Ventricular Ejection Fraction at 3 Months (Overall)
Measured: 3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Left ventricular ejection fraction at 72 hours post-treatment
Measured: 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
Measured: 3 months post-treatment
Serum Troponin Concentrations, 48 Hours (Overall)
Area under the curve of serum troponins measured over 48 hours post-treatment
Measured: 48 hours post-treatment
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Area under the curve of serum troponins measured over 48 hours post-treatment
Measured: 48 hours post-treatment
ST-segment Resolution
Proportion of patients with ST-segment resolution at 4 hours post-dose
Measured: 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start27 Oct 2017
- Primary completion14 Jul 2018
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faraday Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470441
- Sponsor's protocol ID
- FDY-5301-201-US
- Status last verified
- Nov 2021
- First submitted
- 27 Feb 2018
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Adlam D, Zarebinski M, Uren NG, Ptaszynski P, Oldroyd KG, Munir S, Zaman A, Contractor H, Kiss RG, Edes I, Szachniewicz J, Nagy GG, Garcia MJ, Tomcsanyi J, Irving J, Sharp ASP, Musialek P, Lupkovics G, Shirodaria C, Selvanayagam JB, Quinn P, Ng L, Roth M, Insko MA, Haber B, Hill S, Siegel L, Tulloch S, Channon KM. A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing primary PCI. Int J Cardiol. 2022 Jan 15;347:1-7. doi: 10.1016/j.ijcard.2021.11.016. Epub 2021 Nov 12.
PubMed 34774885
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03470441
- Acronym / sponsor ID
- FDY-5301-201-US
- Conditions
- Acute Myocardial Infarction, STEMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Faraday Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 14 Jul 2018 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Posted 14 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called FDY-5301 as a possible treatment to reduce the size of the injury to the heart caused by the heart attack. An experimental drug is one that is being tested and is not approved by the United States Food and Drug Administration (FDA).
A heart attack occurs when a heart (coronary) artery supplying blood to the heart muscle becomes blocked and the heart muscle is injured. You will be having a cardiac catheterization procedure to clear the blockage in your coronary artery that caused your heart attack. This procedure works well but may not completely prevent some injury to the heart muscle which occurs when the blood supply is initially restored to the heart. This is known as "reperfusion injury".
FDY-5301 is a single intravenous injection. About 80 subjects are expected to participate in this study at about 20 research sites in the United States and Europe. Each subject's participation is expected to last about 6 months after receiving the study drug.
Subjects who meet all inclusion criteria will be randomly assigned to one of 4 study groups. Three groups will receive FDY-5301 (low, intermediate, or high dose) and 1 group will receive a placebo.The study drug (FDY-5301 or placebo) will be given through a vein (intravenously) during the catheterization procedure. This is a double-blind study so neither the patient nor study personnel will know whether the dose is active drug or placebo until the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
| Arm | Type | Receives |
|---|---|---|
| FDY-5301 Low Dose | Experimental | Drug: FDY-5301Anticipated n=20 |
| FDY-5301 Intermediate Dose | Experimental | Drug: FDY-5301Anticipated n=20 |
| FDY-5301 High Dose | Experimental | Drug: FDY-5301Anticipated n=20 |
| Placebo | Placebo comparator | Other: PlaceboAnticipated n=20 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDY-5301FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day. | Drug | FDY-5301 High Dose, FDY-5301 Intermediate Dose, FDY-5301 Low Dose |
| PlaceboAlso: SalinePlacebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day. | Other | Placebo |
Primary outcome
Arrhythmias of Interest, 48 Hours (Overall)
Time frame: First 48 hours post-treatment
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Time frame: 48 hours post-treatment
Incidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Arrhythmias of Interest, 14 Days (Overall)
Time frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Time frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
15 secondary outcomes
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Time frame: 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Time frame: 3 months post-treatment
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Time frame: 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Time frame: 3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Time frame: 72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Time frame: 3 months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Time frame: 72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Time frame: 3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Time frame: 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Overall)
Time frame: 3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Time frame: 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Time frame: 3 months post-treatment
Serum Troponin Concentrations, 48 Hours (Overall)
Time frame: 48 hours post-treatment
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Time frame: 48 hours post-treatment
ST-segment Resolution
Time frame: 4 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34774885Adlam D, Zarebinski M, Uren NG, Ptaszynski P, Oldroyd KG, Munir S, Zaman A, Contractor H, Kiss RG, Edes I, Szachniewicz J, Nagy GG, Garcia MJ, Tomcsanyi J, Irving J, Sharp ASP, Musialek P, Lupkovics G, Shirodaria C, Selvanayagam JB, Quinn P, Ng L, Roth M, Insko MA, Haber B, Hill S, Siegel L, Tulloch S, Channon KM. A Randomized, double-blind, dose ranging clinical trial of intravenous FDY-5301 in acute STEMI patients undergoing primary PCI. Int J Cardiol. 2022 Jan 15;347:1-7. doi: 10.1016/j.ijcard.2021.11.016. Epub 2021 Nov 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDY-5301 in people with Acute Myocardial Infarction and STEMI, run by Faraday Pharmaceuticals, Inc. at 23 sites in 4 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 4 inclusion and 12 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Poland, Hungary, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Arrhythmias of Interest, 48 Hours (Overall) (time frame: First 48 hours post-treatment). The study lists 4 primary outcomes in all. 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 NCT03470441, which also lists 1 linked publication.
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 16 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.