- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470441
A Study of Acute Myocardial Infarction Using FDY-5301
A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Budapest, Hungary
- Magyar Honvedseg Egeszsegugyi Kozpont
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Budapest, Hungary
- Budai Irgalmasrendi Korhaz
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Debrecen, Hungary
- Debreceni Egyetem Klinikai Központ, Kardiológiai és Szívsebészeti Klinika
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Miskolc, Hungary
- Borsod-Abaúj-Zemplén Megyei Központi Kórház
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Zalaegerszeg, Hungary
- Zala Megyei Szent Rafael Korhaz
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Grodzisk Mazowiecki, Poland
- Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
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Kraków, Poland
- Samodzielny Publiczny Specjalistyczny Szpital Zachodnii im. Jana Pawła II, Oddział Kardiologii Inwazyjnej
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Lubin, Poland
- Miedziowe Centrum Zdrowia
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Warsaw, Poland
- Klinika Kardiologii Inwazyjnej; Centralny Szpital Kliniczny MSWiA w Warszawie
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Wrocław, Poland
- KLINIKA KARDIOLOGII, 4 Wojskowy Szpital Kliniczny
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Łódź, Poland
- Klinika Elektrokardiologii; Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
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Silesia
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Katowice, Silesia, Poland
- Samodzielny Publiczny Szpital Kliniczny Nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. Prof. Leszka Kieca., III Oddz. Kardiologii
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Dundee, United Kingdom
- Ninewells Hospital and Medical School
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Edinburgh, United Kingdom
- Royal Infirmary of Edinburgh
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Glasgow, United Kingdom
- Golden Jubilee National Hospital
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Devon
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Exeter, Devon, United Kingdom
- Royal Devon and Exeter Hospital Cardiology Department
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Greater Manchester
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Manchester, Greater Manchester, United Kingdom
- Wythenshawe Hospital
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Leicestershire
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Leicester, Leicestershire, United Kingdom
- Glenfield Hospital
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom
- University of Oxford
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Tyne And Wear
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Newcastle Upon Tyne, Tyne And Wear, United Kingdom
- Freeman Hospital
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West Midlands
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Wolverhampton, West Midlands, United Kingdom
- New Cross Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55047
- Minneapolis Heart Institute
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FDY-5301 Low Dose
Anticipated n=20
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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.
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Experimental: FDY-5301 Intermediate Dose
Anticipated n=20
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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.
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Experimental: FDY-5301 High Dose
Anticipated n=20
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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.
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Placebo Comparator: Placebo
Anticipated n=20
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Arrhythmias of Interest, 48 Hours (Overall)
Time Frame: First 48 hours post-treatment
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Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
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First 48 hours post-treatment
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Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Time Frame: 48 hours post-treatment
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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
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48 hours post-treatment
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Arrhythmias of Interest, 14 Days (Overall)
Time Frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
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Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
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48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
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Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Time Frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
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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
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48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
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Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
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72 hours post-treatment
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Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Time Frame: 3 months post-treatment
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Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
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3 months post-treatment
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Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
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Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
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72 hours post-treatment
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Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
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Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
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3 months post-treatment
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Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
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Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
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72 hours post-treatment
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Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Time Frame: 3 months post-treatment
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Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
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3 months post-treatment
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Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
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Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
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72 hours post-treatment
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Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
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Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
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3 months post-treatment
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Left Ventricular Ejection Fraction, 72 Hours (Overall)
Time Frame: 72 hours post-treatment
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Left ventricular ejection fraction at 72 hours post-treatment
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72 hours post-treatment
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Left Ventricular Ejection Fraction, 3 Months (Overall)
Time Frame: 3 months post-treatment
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Left Ventricular Ejection Fraction at 3 Months (Overall)
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3 months post-treatment
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Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Time Frame: 72 hours post-treatment
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Left ventricular ejection fraction at 72 hours post-treatment
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72 hours post-treatment
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Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Time Frame: 3 months post-treatment
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Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
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3 months post-treatment
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Serum Troponin Concentrations, 48 Hours (Overall)
Time Frame: 48 hours post-treatment
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Area under the curve of serum troponins measured over 48 hours post-treatment
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48 hours post-treatment
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Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Time Frame: 48 hours post-treatment
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Area under the curve of serum troponins measured over 48 hours post-treatment
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48 hours post-treatment
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ST-segment Resolution
Time Frame: 4 hours post-dose
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Proportion of patients with ST-segment resolution at 4 hours post-dose
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4 hours post-dose
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shannon Wilson, Faraday Pharmaceuticals, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDY-5301-201-US
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on FDY-5301
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Faraday Pharmaceuticals, Inc.RecruitingAcute Myocardial Infarction | STEMI | Percutaneous Coronary RevascularizationUnited States, Israel, Poland, Portugal, Hungary, Canada
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Faraday Pharmaceuticals, Inc.Terminated