A Study of Acute Myocardial Infarction Using FDY-5301
- Registration Number
- NCT03470441
- Lead Sponsor
- Faraday Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 18-80 year old male subjects
- 18 to 80 year old female subjects who are not of child-bearing potential.
- 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)
- Previous myocardial infarction
- Left bundle branch block (LBBB)
- Previous coronary artery bypass graft surgery (CABG)
- Major hemodynamic instability or uncontrolled ventricular arrhythmias
- Known contraindication to CMR
- Patients with known thyroid disease
- Subjects with past or current renal impairment requiring dialysis
- Pregnant or females of child bearing potential
- Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
- Use of investigational drugs or devices within 30 days prior to enrollment into the study.
- Life expectancy of less than 1 year due to non-cardiac pathology
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FDY-5301 Low Dose FDY-5301 Anticipated n=20 FDY-5301 Intermediate Dose FDY-5301 Anticipated n=20 FDY-5301 High Dose FDY-5301 Anticipated n=20 Placebo Placebo Anticipated n=20
- Primary Outcome Measures
Name Time Method Arrhythmias of Interest, 48 Hours (Overall) First 48 hours post-treatment Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) 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
Arrhythmias of Interest Incidence Rate, 14 Days (Overall) 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
Arrhythmias of Interest, 14 Days (Overall) 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI) Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
- Secondary Outcome Measures
Name Time Method Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) 72 hours post-treatment Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) 3 months post-treatment Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Left Ventricular End Systolic Volume Index, 3 Months (Overall) 3 months post-treatment Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) 72 hours post-treatment Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) 3 months post-treatment Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) 3 months post-treatment Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
Serum Troponin Concentrations, 48 Hours (Overall) 48 hours post-treatment Area under the curve of serum troponins measured over 48 hours post-treatment
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) 48 hours post-treatment Area under the curve of serum troponins measured over 48 hours post-treatment
ST-segment Resolution 4 hours post-dose Proportion of patients with ST-segment resolution at 4 hours post-dose
Left Ventricular End Systolic Volume Index, 72 Hours (Overall) 72 hours post-treatment Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
Infarct Size Relative to Ventricular Volume, 3 Months (Overall) 3 months post-treatment Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) 72 hours post-treatment Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
Left Ventricular Ejection Fraction, 72 Hours (Overall) 72 hours post-treatment Left ventricular ejection fraction at 72 hours post-treatment
Left Ventricular Ejection Fraction, 3 Months (Overall) 3 months post-treatment Left Ventricular Ejection Fraction at 3 Months (Overall)
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) 72 hours post-treatment Left ventricular ejection fraction at 72 hours post-treatment
Trial Locations
- Locations (22)
Budai Irgalmasrendi Kórház
🇭🇺Budapest, Hungary
Magyar Honvédség Egészségügyi Központ
🇭🇺Budapest, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház
🇭🇺Miskolc, Hungary
Miedziowe Centrum Zdrowia
🇵🇱Lubin, Poland
Zala Megyei Szent Rafael Kórház
🇭🇺Zalaegerszeg, Hungary
KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny
🇵🇱Wrocław, Poland
Royal Devon and Exeter Hospital Cardiology Department
🇬🇧Exeter, Devon, United Kingdom
Glenfield Hospital
🇬🇧Leicester, Leicestershire, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika
🇭🇺Debrecen, Hungary
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
🇵🇱Kraków, Poland
Wythenshawe Hospital
🇬🇧Manchester, Greater Manchester, United Kingdom
Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii
🇵🇱Katowice, Silesia, Poland
University of Oxford
🇬🇧Oxford, Oxfordshire, United Kingdom
Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warsaw, Poland
Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
🇵🇱Łódź, Poland
Montefiore Medical Center
🇺🇸Bronx, New York, United States