Acute Myocardial Infarction, STEMI
Conditions
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.
Interventions
DRUGFDY-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.
OTHERPlacebo
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.
Sponsors
Faraday Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
This is a double-blind study where all study staff and participants are blinded to whether the patient receives active drug or placebo.
Intervention model description
All subjects who fulfill all study eligibility criteria will be randomized to receive one of the 4 treatments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (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) |
| 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, 72 Hours (Overall) | 72 hours post-treatment | Left ventricular end systolic volume index (LVESVi) at 72 hours 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, 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 |
| 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 |
Countries
Hungary, Poland, United Kingdom, United States
Participant flow
Recruitment details
The first participant enrolled on October 27, 2017 in study centers in Poland, Hungary, UK, and the United States.
Pre-assignment details
A total of 120 subjects were randomized 3:1 to receive one of three dosage amounts of study drug or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Experimental FDY-5301 Low Dose 0.5 mg/kg FDY-5301 | 29 |
| Experimental FDY-5301 Intermediate Dose 1.0 mg/kg FDY-5301 | 31 |
| Experimental FDY-5301 High Dose 2.0 mg/kg FDY-5301 | 31 |
| Placebo Placebo | 29 |
| Total | 120 |
Baseline characteristics
| Characteristic | Experimental FDY-5301 Low Dose | Experimental FDY-5301 Intermediate Dose | Experimental FDY-5301 High Dose | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 9 Participants | 14 Participants | 11 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 22 Participants | 17 Participants | 18 Participants | 71 Participants |
| BMI | 27.1 kg/m2 STANDARD_DEVIATION 4.17 | 28 kg/m2 STANDARD_DEVIATION 4.29 | 28.1 kg/m2 STANDARD_DEVIATION 4.88 | 28.5 kg/m2 STANDARD_DEVIATION 4.43 | 27.9 kg/m2 STANDARD_DEVIATION 4.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 30 Participants | 30 Participants | 28 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 173 cm STANDARD_DEVIATION 7.8 | 171 cm STANDARD_DEVIATION 8.2 | 170 cm STANDARD_DEVIATION 10.7 | 170 cm STANDARD_DEVIATION 8.3 | 171 cm STANDARD_DEVIATION 8.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 29 Participants | 27 Participants | 30 Participants | 27 Participants | 113 Participants |
| Region of Enrollment Hungary | 7 participants | 8 participants | 9 participants | 6 participants | 30 participants |
| Region of Enrollment Poland | 7 participants | 5 participants | 6 participants | 2 participants | 20 participants |
| Region of Enrollment United Kingdom | 15 participants | 16 participants | 15 participants | 18 participants | 64 participants |
| Region of Enrollment United States | 0 participants | 2 participants | 1 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 11 Participants | 10 Participants | 37 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 20 Participants | 19 Participants | 83 Participants |
| Weight | 81.62 kg STANDARD_DEVIATION 14.703 | 81.76 kg STANDARD_DEVIATION 13.453 | 81.52 kg STANDARD_DEVIATION 15.749 | 82.23 kg STANDARD_DEVIATION 15.162 | 81.78 kg STANDARD_DEVIATION 14.601 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 1 / 31 | 1 / 31 | 1 / 29 |
| other Total, other adverse events | 9 / 29 | 4 / 31 | 9 / 31 | 18 / 29 |
| serious Total, serious adverse events | 7 / 29 | 7 / 31 | 4 / 31 | 8 / 29 |
Outcome results
Primary
Arrhythmias of Interest, 14 Days (Overall)
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
Time frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 14 Days (Overall) | High-Degree AV Block | 0 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 14 Days (Overall) | Atrial Fibrillation | 3 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 14 Days (Overall) | Ventricular Fibrillation | 0 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 1 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 14 Days (Overall) | High-Degree AV Block | 0 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 14 Days (Overall) | Atrial Fibrillation | 2 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 14 Days (Overall) | Ventricular Fibrillation | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 14 Days (Overall) | Ventricular Fibrillation | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 14 Days (Overall) | High-Degree AV Block | 2 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 14 Days (Overall) | Atrial Fibrillation | 2 participants |
| Placebo | Arrhythmias of Interest, 14 Days (Overall) | High-Degree AV Block | 0 participants |
| Placebo | Arrhythmias of Interest, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Placebo | Arrhythmias of Interest, 14 Days (Overall) | Ventricular Fibrillation | 0 participants |
| Placebo | Arrhythmias of Interest, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0 participants |
| Placebo | Arrhythmias of Interest, 14 Days (Overall) | Atrial Fibrillation | 1 participants |
Primary
Arrhythmias of Interest, 48 Hours (Overall)
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Time frame: First 48 hours post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 48 Hours (Overall) | High-Degree AV Block | 0 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 48 Hours (Overall) | Atrial Fibrillation | 0 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | 1 participants |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest, 48 Hours (Overall) | Ventricular Fibrillation | 0 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | 1 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 48 Hours (Overall) | High-Degree AV Block | 0 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 48 Hours (Overall) | Atrial Fibrillation | 2 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest, 48 Hours (Overall) | Ventricular Fibrillation | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | 7 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 48 Hours (Overall) | Ventricular Fibrillation | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 48 Hours (Overall) | High-Degree AV Block | 2 participants |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest, 48 Hours (Overall) | Atrial Fibrillation | 1 participants |
| Placebo | Arrhythmias of Interest, 48 Hours (Overall) | High-Degree AV Block | 0 participants |
| Placebo | Arrhythmias of Interest, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 participants |
| Placebo | Arrhythmias of Interest, 48 Hours (Overall) | Ventricular Fibrillation | 0 participants |
| Placebo | Arrhythmias of Interest, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | 2 participants |
| Placebo | Arrhythmias of Interest, 48 Hours (Overall) | Atrial Fibrillation | 1 participants |
descriptive
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
Time frame: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | High-Degree AV Block | 0 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Atrial Fibrillation | 0.0475 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Ventricular Fibrillation | 0 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0.0147 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | High-Degree AV Block | 0 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Atrial Fibrillation | 0.0293 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Ventricular Fibrillation | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Ventricular Fibrillation | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | High-Degree AV Block | 0.0295 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Atrial Fibrillation | 0.0295 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | High-Degree AV Block | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Ventricular Fibrillation | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Non-Sustained Ventricular Tachycardia | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 14 Days (Overall) | Atrial Fibrillation | 0.0166 Percentage |
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
Time frame: 48 hours post-treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | High-Degree AV Block | 0 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Atrial Fibrillation | 0 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | .0766 Percentage |
| Experimental FDY-5301 Low Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Ventricular Fibrillation | 0 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | .0797 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | High-Degree AV Block | 0 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Atrial Fibrillation | .159 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 Intermediate Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Ventricular Fibrillation | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | .548 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Ventricular Fibrillation | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | High-Degree AV Block | .157 Percentage |
| Experimental FDY-5301 High Dose | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Atrial Fibrillation | .0783 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | High-Degree AV Block | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Sustained Ventricular Tachycardia | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Ventricular Fibrillation | 0 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Non-Sustained Ventricular Tachycardia | .168 Percentage |
| Placebo | Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) | Atrial Fibrillation | .0838 Percentage |
Secondary
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Time frame: 3 months post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 19.7 INF/VV (%) |
| Experimental FDY-5301 Intermediate Dose | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 10.4 INF/VV (%) |
| Experimental FDY-5301 High Dose | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 9.3 INF/VV (%) |
| Placebo | Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) | 22.8 INF/VV (%) |
Comparison: Wilcoxon Mann-Whitney Test Comparing placebo to anterior infarcts FDY-5301 treated subjects (low, intermediate, and high) combined into one group.p-value: 0.4695.16% CI: [-20.2, 12.1]Wilcoxon (Mann-Whitney)
Secondary
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Time frame: 3 months post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 11.7 INF/VV (%) |
| Experimental FDY-5301 Intermediate Dose | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 11.4 INF/VV (%) |
| Experimental FDY-5301 High Dose | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 8.5 INF/VV (%) |
| Placebo | Infarct Size Relative to Ventricular Volume, 3 Months (Overall) | 14.9 INF/VV (%) |
Comparison: Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).p-value: 0.3295.15% CI: [-10.8, 3.1]Wilcoxon (Mann-Whitney)
Secondary
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
Time frame: 72 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 33 INF/VV (%) |
| Experimental FDY-5301 Intermediate Dose | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 15.8 INF/VV (%) |
| Experimental FDY-5301 High Dose | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 12.1 INF/VV (%) |
| Placebo | Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) | 26.7 INF/VV (%) |
Secondary
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
Time frame: 72 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 19.1 INF/VV (%) |
| Experimental FDY-5301 Intermediate Dose | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 16.9 INF/VV (%) |
| Experimental FDY-5301 High Dose | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 19.6 INF/VV (%) |
| Placebo | Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) | 20.4 INF/VV (%) |
Secondary
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
Time frame: 3 months post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | 55.7 Percentage |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | 57.2 Percentage |
| Experimental FDY-5301 High Dose | Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | 67.6 Percentage |
| Placebo | Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) | 50.4 Percentage |
Comparison: Wilcoxon Mann-Whitney Test comparing placebo to anterior infarcts FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).p-value: 0.3195.16% CI: [-7, 16.9]Wilcoxon (Mann-Whitney)
Secondary
Left Ventricular Ejection Fraction, 3 Months (Overall)
Left Ventricular Ejection Fraction at 3 Months (Overall)
Time frame: 3 months post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular Ejection Fraction, 3 Months (Overall) | 59.5 Percentage |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular Ejection Fraction, 3 Months (Overall) | 58.9 Percentage |
| Experimental FDY-5301 High Dose | Left Ventricular Ejection Fraction, 3 Months (Overall) | 63.2 Percentage |
| Placebo | Left Ventricular Ejection Fraction, 3 Months (Overall) | 53.9 Percentage |
Comparison: Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).p-value: 0.2595.11% CI: [-3.6, 10.6]Wilcoxon (Mann-Whitney)
Secondary
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Left ventricular ejection fraction at 72 hours post-treatment
Time frame: 72 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | 48 Percentage |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | 51.7 Percentage |
| Experimental FDY-5301 High Dose | Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | 57.3 Percentage |
| Placebo | Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) | 43.2 Percentage |
Secondary
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Left ventricular ejection fraction at 72 hours post-treatment
Time frame: 72 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular Ejection Fraction, 72 Hours (Overall) | 51.4 Percentage |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular Ejection Fraction, 72 Hours (Overall) | 51.7 Percentage |
| Experimental FDY-5301 High Dose | Left Ventricular Ejection Fraction, 72 Hours (Overall) | 54.5 Percentage |
| Placebo | Left Ventricular Ejection Fraction, 72 Hours (Overall) | 48.7 Percentage |
Secondary
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Time frame: 3 months post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | 37 mL/kg/M2 |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | 28 mL/kg/M2 |
| Experimental FDY-5301 High Dose | Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | 23.5 mL/kg/M2 |
| Placebo | Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) | 36 mL/kg/M2 |
Secondary
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Time frame: 3 months post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 29 mL/kg/M2 |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 25.5 mL/kg/M2 |
| Experimental FDY-5301 High Dose | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 27 mL/kg/M2 |
| Placebo | Left Ventricular End Systolic Volume Index, 3 Months (Overall) | 36 mL/kg/M2 |
Secondary
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
Time frame: 72 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | 45.5 mL/kg/M2 |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | 32 mL/kg/M2 |
| Experimental FDY-5301 High Dose | Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | 31 mL/kg/M2 |
| Placebo | Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) | 42 mL/kg/M2 |
Secondary
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
Time frame: 72 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 40 mL/kg/M2 |
| Experimental FDY-5301 Intermediate Dose | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 32 mL/kg/M2 |
| Experimental FDY-5301 High Dose | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 32 mL/kg/M2 |
| Placebo | Left Ventricular End Systolic Volume Index, 72 Hours (Overall) | 38 mL/kg/M2 |
Secondary
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Area under the curve of serum troponins measured over 48 hours post-treatment
Time frame: 48 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | 123 AUC4-48 µg/L |
| Experimental FDY-5301 Intermediate Dose | Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | 55 AUC4-48 µg/L |
| Experimental FDY-5301 High Dose | Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | 111 AUC4-48 µg/L |
| Placebo | Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) | 83.8 AUC4-48 µg/L |
Secondary
Serum Troponin Concentrations, 48 Hours (Overall)
Area under the curve of serum troponins measured over 48 hours post-treatment
Time frame: 48 hours post-treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental FDY-5301 Low Dose | Serum Troponin Concentrations, 48 Hours (Overall) | 90.5 AUC4-48 µg/L |
| Experimental FDY-5301 Intermediate Dose | Serum Troponin Concentrations, 48 Hours (Overall) | 98.1 AUC4-48 µg/L |
| Experimental FDY-5301 High Dose | Serum Troponin Concentrations, 48 Hours (Overall) | 108 AUC4-48 µg/L |
| Placebo | Serum Troponin Concentrations, 48 Hours (Overall) | 112 AUC4-48 µg/L |
Secondary
ST-segment Resolution
Proportion of patients with ST-segment resolution at 4 hours post-dose
Time frame: 4 hours post-dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental FDY-5301 Low Dose | ST-segment Resolution | 48.0 percentage |
| Experimental FDY-5301 Intermediate Dose | ST-segment Resolution | 68.0 percentage |
| Experimental FDY-5301 High Dose | ST-segment Resolution | 52.4 percentage |
| Placebo | ST-segment Resolution | 47.4 percentage |