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.
Brief Title
A Study of Acute Myocardial Infarction Using FDY-5301
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Myocardial Infarction
STEMI
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
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
Inclusion 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)
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)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT03470441
Org Class
Industry
Org Full Name
Faraday Pharmaceuticals, Inc.
Org Study Id
FDY-5301-201-US
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intravenous FDY-5301 in Acute Myocardial Infarction
Primary Outcomes
Outcome Description
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Outcome Measure
Arrhythmias of Interest, 48 Hours (Overall)
Outcome Time Frame
First 48 hours post-treatment
Outcome Description
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
Outcome Measure
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Outcome Time Frame
48 hours post-treatment
Outcome Description
Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
Outcome Measure
Arrhythmias of Interest, 14 Days (Overall)
Outcome Time Frame
48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Outcome Description
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
Outcome Measure
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Outcome Time Frame
48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)
Secondary Outcomes
Outcome Description
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
Outcome Time Frame
72 hours post-treatment
Outcome Measure
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
Outcome Description
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Outcome Time Frame
3 months post-treatment
Outcome Measure
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
Outcome Description
Infarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
Outcome Time Frame
72 hours post-treatment
Outcome Measure
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
Outcome Description
Infarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Outcome Time Frame
3 months post-treatment
Outcome Measure
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
Outcome Description
Left ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
Outcome Time Frame
72 hours post-treatment
Outcome Measure
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
Outcome Description
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Outcome Time Frame
3 months post-treatment
Outcome Measure
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
Outcome Description
Left ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
Outcome Time Frame
72 hours post-treatment
Outcome Measure
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
Outcome Description
Left ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Outcome Time Frame
3 months post-treatment
Outcome Measure
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
Outcome Description
Left ventricular ejection fraction at 72 hours post-treatment
Outcome Time Frame
72 hours post-treatment
Outcome Measure
Left Ventricular Ejection Fraction, 72 Hours (Overall)
Outcome Description
Left Ventricular Ejection Fraction at 3 Months (Overall)
Outcome Time Frame
3 months post-treatment
Outcome Measure
Left Ventricular Ejection Fraction, 3 Months (Overall)
Outcome Description
Left ventricular ejection fraction at 72 hours post-treatment
Outcome Time Frame
72 hours post-treatment
Outcome Measure
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
Outcome Description
Left Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
Outcome Time Frame
3 months post-treatment
Outcome Measure
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
Outcome Description
Area under the curve of serum troponins measured over 48 hours post-treatment
Outcome Time Frame
48 hours post-treatment
Outcome Measure
Serum Troponin Concentrations, 48 Hours (Overall)
Outcome Description
Area under the curve of serum troponins measured over 48 hours post-treatment
Outcome Time Frame
48 hours post-treatment
Outcome Measure
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
Outcome Description
Proportion of patients with ST-segment resolution at 4 hours post-dose
Outcome Time Frame
4 hours post-dose
Outcome Measure
ST-segment Resolution
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mario Garcia
Investigator Email
mariogar@montefiore.org
Investigator Phone
718-920-4172