Anterior ST-Elevation Myocardial Infarction MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Faraday Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Anterior STEMI, based on: Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) and Electrocardiogram (ECG) criteria: • men > 40 years: = 2 mm of ST elevation in V2 and V3 • men = 40 years: = 2.5 mm of ST elevation in V2 and V3 • women = 1.5 mm of ST elevation in V2 and V3 3. Planned primary PCI to occur = 6 hours of onset of persistent symptoms that causes the patient to pursue medical care for myocardial infarction. 4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for 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 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3600
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 1 year due to non-cardiac pathology 2. Known thyroid disease or thyroid disorder, including subjects on thyroid hormone replacement therapy at the time of randomization 3. Known allergy to iodine or the excipient of the investigational product (sodium chloride) 4. Renal disease requiring dialysis 5. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization 6. Body weight >140 kg (or 309 lbs) 7. Use of thrombolytic therapy as treatment for the index STEMI event 8. Use of investigational drugs within 30 days or 5 half-lives whichever is longer, prior to randomization or the use of investigational devices within 30 days prior to randomization 9. Any clinically significant abnormality identified prior to randomization that in the judgment of the Investigator or Sponsor would preclude safe completion of the study, or confound the anticipated benefit of FDY-5301
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI.;Secondary Objective: To assess the effect of FDY-5301 on other clinical outcomes such as all-cause mortality and cardiovascular outcomes in subjects with an anterior STEMI undergoing pPCI;Primary end point(s): The proportion of subjects who experience either cardiovascular mortality (defined as deaths which are sudden and due to presumed arrhythmia, or deaths due to presumed or confirmed thromboembolic CVA, presumed or confirmed pulmonary embolism, cardiac rupture, heart failure, recurrent myocardial infarction [e.g., remote or stent thrombosis], and deaths due to procedural efforts to treat these defined cardiac events), or a heart failure event through Month 12;Timepoint(s) of evaluation of this end point: through month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The proportion of subjects who experience either all-cause mortality or a heart failure event through Month 12 •The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through Month 12 •The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events of thromboembolic cerebral vascular accident (CVA), ventricular aneurysm/hemorrhage, recurrent myocardial infarction (e.g., remote or stent thrombosis), or persistent arrhythmia requiring intervention (e.g. ventricular fibrillation, sustained ventricular tachycardia, or bradyarrhythmia requiring intervention) through Month 12 •Serum troponin T at Day 3 ;Timepoint(s) of evaluation of this end point: see E.5.2 for evaluation timing | — |
Countries
Canada, Czechia, Czech Republic, Germany, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactMedpace Regulatory Submissions
Medpace Inc.
Outcome results
None listed