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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03470441
Other study ID # FDY-5301-201-US
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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