A Study of Acute Myocardial Infarction Using FDY-5301

November 16, 2021 updated by: Faraday Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Budapest, Hungary
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary
        • Budai Irgalmasrendi Korhaz
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika
      • Miskolc, Hungary
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház
      • Zalaegerszeg, Hungary
        • Zala Megyei Szent Rafael Korhaz
      • Grodzisk Mazowiecki, Poland
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
      • Kraków, Poland
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
      • Lubin, Poland
        • Miedziowe Centrum Zdrowia
      • Warsaw, Poland
        • Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie
      • Wrocław, Poland
        • KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny
      • Łódź, Poland
        • Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
    • Silesia
      • Katowice, Silesia, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii
      • Dundee, United Kingdom
        • Ninewells Hospital and Medical School
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
    • Devon
      • Exeter, Devon, United Kingdom
        • Royal Devon and Exeter Hospital Cardiology Department
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
        • Wythenshawe Hospital
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom
        • Glenfield Hospital
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • University of Oxford
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom
        • Freeman Hospital
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom
        • New Cross Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55047
        • Minneapolis Heart Institute
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDY-5301 Low Dose
Anticipated n=20
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.
Experimental: FDY-5301 Intermediate Dose
Anticipated n=20
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.
Experimental: FDY-5301 High Dose
Anticipated n=20
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.
Placebo Comparator: Placebo
Anticipated n=20
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.
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
48 hours post-treatment
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.
48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
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
48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
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 (INF/VV) at 3 months post-treatment)
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 (INF/VV) at 72 hours post-treatment)
72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
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 (LVESVi) at 72 hours post-treatment
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 (LVESVi) at 3 Months post-treatment
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 (LVESVi) at 72 Hours post-treatment
72 hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
Left ventricular ejection fraction at 72 hours post-treatment
72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Overall)
Time Frame: 3 months post-treatment
Left Ventricular Ejection Fraction at 3 Months (Overall)
3 months post-treatment
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
Left ventricular ejection fraction at 72 hours post-treatment
72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
3 months post-treatment
Serum Troponin Concentrations, 48 Hours (Overall)
Time Frame: 48 hours post-treatment
Area under the curve of serum troponins measured over 48 hours post-treatment
48 hours post-treatment
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Time Frame: 48 hours post-treatment
Area under the curve of serum troponins measured over 48 hours post-treatment
48 hours post-treatment
ST-segment Resolution
Time Frame: 4 hours post-dose
Proportion of patients with ST-segment resolution at 4 hours post-dose
4 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Shannon Wilson, Faraday Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2017

Primary Completion (Actual)

July 14, 2018

Study Completion (Actual)

January 3, 2019

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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