Acute Myocardial Infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Faraday Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-80 year old male subjects 2. 18 to 80 year old female subjects who are not of childbearing potential 3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the Jpoint 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 4. Assent/Informed consent to study participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
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 (e.g. pacemaker) 6. Patients with known thyroid disease, or known allergy to iodide 7. Subjects with past or current renal impairment requiring dialysis 8. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2 9. Use of investigational drugs or devices within 30 days prior to enrollment into the study 10. Life expectancy of less than 1 year due to non-cardiac pathology 11. 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 |
|---|---|
| Main Objective: To evaluate the safety, efficacy and pharmacokinetics (PK) of 3 dose levels of FDY-5301 compared to placebo in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).;Secondary Objective: To examine the effect of FDY-5301 on heart function (assessed using cardiac MRI) and its effect on cardiac biomarkers (e.g. troponin I);Primary end point(s): The primary outcome for this study will be the combined number and incidence rate of several arrhythmias of interest for 14 days post study drug. These arrhythmias include ventricular fibrillation, sustained and non-sustained ventricular tachycardia and high degree AV block. Continuous cardiac monitoring will occur for 14 days post PCI by means of wearable patch devices.;Timepoint(s) of evaluation of this end point: 14 days post study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Infarct size parameters will be assessed by cardiac magnetic resonance (CMR) at 72 +/-24 hours post-study drug and 3 months post-study drug; the following will be compared between groups; infarct size as a proportion of ventricular volume (INF/VV), myocardial salvage index (MSI) and absolute myocardial infarction size (INF) 2. The proportion of patients with ST-segment resolution at 4 hours post-study drug 3. Serum levels of troponin calculated as AUC over 48 hours post treatment 4. Persistent arrhythmias at 30 days and 3 months 5. Measures of cardiac function by CMR including enddiastolic volume (EDV), end-systolic volume (ESV), fractional shortening (FS) and ejection fraction (EF) at discharge and 3 months 6. Biomarkers of cardiac injury, inflammation and remodeling out to 3 months of follow up 7. Cardiac related adverse events including the development of heart failure out to 3 months of follow up 8. Incidence of all cause and cardiac mortality out to 6 months of follow up;Timepoint(s) of evaluation of this end point: 1. 72 +/-24 hours post-study drug and 3 months post-study drug 3. 4 hours post study drug 3. 48 hours post treatment 4. at 30 days and 3 months 5. at discharge and 3 months 6. 3 months of follow up 7. to 3 months of follow up 8. to 6 months of follow up | — |
Countries
Hungary, Poland, United Kingdom, United States
Contacts
Public ContactPoint Clinical Operations
Faraday Pharmaceuticals Inc.
Outcome results
None listed