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A Study of Acute Myocardial Infarction Using FDY-5301

NCT ID: NCT03470441

Last Updated: 2021-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2019-01-03

Brief Summary

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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

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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

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Acute Myocardial Infarction STEMI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.

Study Groups

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FDY-5301 Low Dose

Anticipated n=20

Group Type EXPERIMENTAL

FDY-5301

Intervention Type DRUG

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.

FDY-5301 Intermediate Dose

Anticipated n=20

Group Type EXPERIMENTAL

FDY-5301

Intervention Type DRUG

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.

FDY-5301 High Dose

Anticipated n=20

Group Type EXPERIMENTAL

FDY-5301

Intervention Type DRUG

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

Anticipated n=20

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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FDY-5301

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.

Intervention Type DRUG

Placebo

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.

Intervention Type OTHER

Other Intervention Names

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Saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faraday Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon Wilson

Role: STUDY_DIRECTOR

Faraday Pharmaceuticals, Inc.

Locations

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Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Budai Irgalmasrendi Kórház

Budapest, , Hungary

Site Status

Magyar Honvédség Egészségügyi Központ

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika

Debrecen, , Hungary

Site Status

Borsod-Abaúj-Zemplén Megyei Központi Kórház

Miskolc, , Hungary

Site Status

Zala Megyei Szent Rafael Kórház

Zalaegerszeg, , Hungary

Site Status

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

Site Status

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

Grodzisk Mazowiecki, , Poland

Site Status

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

Krakow, , Poland

Site Status

Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodz, , Poland

Site Status

Miedziowe Centrum Zdrowia

Lubin, , Poland

Site Status

Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Site Status

KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny

Wroclaw, , Poland

Site Status

Royal Devon and Exeter Hospital Cardiology Department

Exeter, Devon, United Kingdom

Site Status

Wythenshawe Hospital

Manchester, Greater Manchester, United Kingdom

Site Status

Glenfield Hospital

Leicester, Leicestershire, United Kingdom

Site Status

University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status

Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

New Cross Hospital

Wolverhampton, West Midlands, United Kingdom

Site Status

Ninewells Hospital and Medical School

Dundee, , United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Golden Jubilee National Hospital

Glasgow, , United Kingdom

Site Status

Countries

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United States Hungary Poland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 34774885 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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FDY-5301-201-US

Identifier Type: -

Identifier Source: org_study_id