Clinical trial NCT03470441: A Study of Acute Myocardial Infarction Using FDY-5301
Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
STEMI
Lead sponsor: Faraday Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Arrhythmias of Interest, 48 Hours (Overall)
timeFrame: First 48 hours post-treatment
measure: Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
timeFrame: 48 hours post-treatment
measure: Arrhythmias of Interest, 14 Days (Overall)
timeFrame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
measure: Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
timeFrame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Secondary outcomes:
measure: Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
timeFrame: 72 hours post-treatment
measure: Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
timeFrame: 3 months post-treatment
measure: Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
timeFrame: 72 hours post-treatment
measure: Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
timeFrame: 3 months post-treatment
measure: Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
timeFrame: 72 hours post-treatment
measure: Left Ventricular End Systolic Volume Index, 3 Months (Overall)
timeFrame: 3 months post-treatment
measure: Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
timeFrame: 72 hours post-treatment
measure: Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
timeFrame: 3 months post-treatment
measure: Left Ventricular Ejection Fraction, 72 Hours (Overall)
timeFrame: 72 hours post-treatment
measure: Left Ventricular Ejection Fraction, 3 Months (Overall)
timeFrame: 3 months post-treatment
measure: Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
timeFrame: 72 hours post-treatment
measure: Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
timeFrame: 3 months post-treatment
measure: Serum Troponin Concentrations, 48 Hours (Overall)
timeFrame: 48 hours post-treatment
measure: Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
timeFrame: 48 hours post-treatment
measure: ST-segment Resolution
timeFrame: 4 hours post-dose
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Kórház
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Szent Rafael Kórház
city: Katowice
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii
state: Silesia
city: Grodzisk Mazowiecki
country: Poland
facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
city: Kraków
country: Poland
facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia
city: Warsaw
country: Poland
facility: Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie
city: Wrocław
country: Poland
facility: KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny
city: Łódź
country: Poland
facility: Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital Cardiology Department
state: Devon
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: Greater Manchester
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
state: Leicestershire
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
state: Tyne And Wear
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: Faraday Pharmaceuticals, Inc.
name: Shannon Wilson
role: STUDY_DIRECTOR
References:
citation: 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.