Anterior ST-Elevation Myocardial Infarction
Conditions
Brief summary
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 cerebral vascular accident, 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
Detailed description
1. The proportion of subjects who experience either all-cause mortality or a heart failure event through Month 12, 2. The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through Month 12, 3. The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: 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, 4. Serum troponin T at Day 3
Interventions
DRUGThe placebo product is manufactured to visually match the corresponding FDY-5301 injection drug product. It is formulated to match a standard saline solution comprised of Sodium Chloride
and Water for Injection.
Sponsors
Faraday Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 cerebral vascular accident, 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of subjects who experience either all-cause mortality or a heart failure event through Month 12, 2. The total number of cardiovascular events defined as cardiovascular mortality and heart failure events through Month 12, 3. The proportion of subjects who experience a composite of the following specified non-fatal cardiovascular events: 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, 4. Serum troponin T at Day 3 | — |
Countries
Czechia, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Spain
Outcome results
None listed