E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anterior ST-Elevation Myocardial Infarction |
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E.1.1.1 | Medical condition in easily understood language |
Myocardial Infarct (heart attack) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064346 |
E.1.2 | Term | STEMI |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effect of FDY-5301 on cardiovascular mortality and heart failure events in subjects with an anterior STEMI undergoing pPCI. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 of 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
see E.5.2 for evaluation timing |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Israel |
United Kingdom |
United States |
Czechia |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Portugal |
Slovakia |
Spain |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |