A Study of Acute Myocardial Infarction Using FDY-5301

Acute Myocardial Infarction Clinical Trial

Official title:

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470441
• Other study ID #: FDY-5301-201-US
• Status: Completed
• Phase: Phase 2
• Start date: October 27, 2017
• Est. completion date: January 3, 2019

Study information

• Verified date: November 2021
• Source: Faraday Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 3, 2019
• Est. primary completion date: July 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• STEMI

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Hungary	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
Poland	Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawla II, Oddzial Kardiologii Inwazyjnej	Grodzisk Mazowiecki
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach, Górnoslaskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii	Katowice	Silesia
Poland	Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawla II, Oddzial Kardiologii Inwazyjnej	Kraków
Poland	Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Miedziowe Centrum Zdrowia	Lubin
Poland	Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw
Poland	KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny	Wroclaw
United Kingdom	Ninewells Hospital and Medical School	Dundee
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital Cardiology Department	Exeter	Devon
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Glenfield Hospital	Leicester	Leicestershire
United Kingdom	Wythenshawe Hospital	Manchester	Greater Manchester
United Kingdom	Freeman Hospital	Newcastle Upon Tyne	Tyne And Wear
United Kingdom	University of Oxford	Oxford	Oxfordshire
United Kingdom	New Cross Hospital	Wolverhampton	West Midlands
United States	Montefiore Medical Center	Bronx	New York
United States	Minneapolis Heart Institute	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Faraday Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmias of Interest, 48 Hours (Overall)	Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.	First 48 hours post-treatment
Primary	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	48 hours post-treatment
Primary	Arrhythmias of Interest, 14 Days (Overall)	Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.	48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Primary	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	48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Secondary	Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)	Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment	72 hours post-treatment
Secondary	Infarct Size Relative to Ventricular Volume, 3 Months (Overall)	Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)	3 months post-treatment
Secondary	Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)	Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)	72 hours post-treatment
Secondary	Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)	Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)	3 months post-treatment
Secondary	Left Ventricular End Systolic Volume Index, 72 Hours (Overall)	Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment	72 hours post-treatment
Secondary	Left Ventricular End Systolic Volume Index, 3 Months (Overall)	Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment	3 months post-treatment
Secondary	Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)	Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment	72 hours post-treatment
Secondary	Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)	Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment	3 months post-treatment
Secondary	Left Ventricular Ejection Fraction, 72 Hours (Overall)	Left ventricular ejection fraction at 72 hours post-treatment	72 hours post-treatment
Secondary	Left Ventricular Ejection Fraction, 3 Months (Overall)	Left Ventricular Ejection Fraction at 3 Months (Overall)	3 months post-treatment
Secondary	Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)	Left ventricular ejection fraction at 72 hours post-treatment	72 hours post-treatment
Secondary	Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)	Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)	3 months post-treatment
Secondary	Serum Troponin Concentrations, 48 Hours (Overall)	Area under the curve of serum troponins measured over 48 hours post-treatment	48 hours post-treatment
Secondary	Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)	Area under the curve of serum troponins measured over 48 hours post-treatment	48 hours post-treatment
Secondary	ST-segment Resolution	Proportion of patients with ST-segment resolution at 4 hours post-dose	4 hours post-dose