Phase 2
N=120
A Study of Acute Myocardial Infarction Using FDY-5301
Acute Myocardial Infarction · STEMI
Bottom Line
View on ClinicalTrials.gov: NCT03470441 ↗Enrolled (actual)
120
Serious AEs
21.7%
Results posted
Dec 2021
Primary outcome: Primary: Arrhythmias of Interest, 48 Hours (Overall) — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FDY-5301 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Faraday Pharmaceuticals, Inc.
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arrhythmias of Interest, 48 Hours (Overall) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Arrhythmias of Interest Incidence Rate, 48 Hours (Overall) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Arrhythmias of Interest, 14 Days (Overall) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Arrhythmias of Interest Incidence Rate, 14 Days (Overall) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Infarct Size Relative to Ventricular Volume, 72 Hours (Overall) |
19.1; 16.9; 19.6; 20.4 | — |
| SECONDARY Infarct Size Relative to Ventricular Volume, 3 Months (Overall) |
11.7; 11.4; 8.5; 14.9 | 0.32 |
| SECONDARY Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts) |
33; 15.8; 12.1; 26.7 | — |
| SECONDARY Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts) |
19.7; 10.4; 9.3; 22.8 | 0.46 |
| SECONDARY Left Ventricular End Systolic Volume Index, 72 Hours (Overall) |
40; 32; 32; 38 | — |
| SECONDARY Left Ventricular End Systolic Volume Index, 3 Months (Overall) |
29; 25.5; 27; 36 | — |
| SECONDARY Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts) |
45.5; 32; 31; 42 | — |
| SECONDARY Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts) |
37; 28; 23.5; 36 | — |
| SECONDARY Left Ventricular Ejection Fraction, 72 Hours (Overall) |
51.4; 51.7; 54.5; 48.7 | — |
| SECONDARY Left Ventricular Ejection Fraction, 3 Months (Overall) |
59.5; 58.9; 63.2; 53.9 | 0.25 |
| SECONDARY Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts) |
48; 51.7; 57.3; 43.2 | — |
| SECONDARY Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts) |
55.7; 57.2; 67.6; 50.4 | 0.31 |
| SECONDARY Serum Troponin Concentrations, 48 Hours (Overall) |
90.5; 98.1; 108; 112 | — |
| SECONDARY Serum Troponin Concentrations, 48 Hours (Anterior Infarcts) |
123; 55; 111; 83.8 | — |
| SECONDARY ST-segment Resolution |
48.0; 68.0; 52.4; 47.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03470441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.