E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anterior ST-Elevation Myocardial Infarction |
Infarto de miocardio con elevación del segmento ST (IMEST) anterior |
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E.1.1.1 | Medical condition in easily understood language |
Myocardial Infarct (heart attack) |
Infarto de miocardio (ataque cardíaco) |
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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 | 100000004849 |
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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. |
Evaluar el efecto de FDY-5301 sobre la mortalidad de origen cardiovascular y los episodios de insuficiencia cardíaca en sujetos con IMEST anterior sometidos a una ICPp. |
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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 |
Evaluar el efecto de FDY-5301 sobre otros resultados clínicos, como mortalidad global y resultados cardiovasculares, en sujetos con IMEST anterior sometidos a una ICPp. |
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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 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 first symptoms of myocardial ischemia 4. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved consent obtained for study participation |
1. Edad ≥18 años. 2. IMEST anterior, basado en: Síntomas de isquemia miocárdica (como dolor torácico, disnea, dolor mandibular, dolor en el brazo, diaforesis o cualquier equivalente anginoso) y Criterios electrocardiográficos: • Varones >40 años: ≥2 mm de elevación del segmento ST en V2 y V3. • Varones ≤40 años: ≥2,5 mm de elevación del segmento ST en V2 y V3. • Mujeres: ≥1,5 mm de elevación del segmento ST en V2 y V3. 3. Previsión de practicar la ICPp en un plazo no superior a 6 horas desde la aparición de los primeros síntomas de isquemia miocárdica 4. Obtención del consentimiento aprobado por el Comité de Ética de la Investigación con medicamentos (CEIm) para participar en el estudio. |
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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 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 or devices 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 |
1. Esperanza de vida inferior a un año debido a enfermedades extracardíacas. 2. Enfermedad o trastorno tiroideo conocido, incluidos los sujetos que estén recibiendo tratamiento de reposición con hormonas tiroideas en el momento de la aleatorización. 3. Alergia conocida al yodo. 4. Nefropatía con necesidad de diálisis. 5. Mujeres embarazadas o en período de lactancia. Las mujeres con capacidad de procrear deberán dar negativo en una prueba de embarazo realizada antes de la aleatorización. 6. Peso corporal >140 kg. 7. Uso de tratamiento trombolítico para el episodio de IMEST de referencia. 8. Uso de fármacos o dispositivos experimentales en los 30 días previos a la aleatorización 9. Cualquier anomalía clínicamente significativa identificada antes de la aleatorización que, en opinión del investigador o promotor, pueda impedir la finalización segura del estudio o confundir la interpretación de los beneficios previstos de 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 |
Proporción de sujetos con muerte de origen cardiovascular (definida como muertes súbitas y debidas a una presunta arritmia, muertes por accidente cerebrovascular tromboembólico presunto o confirmado, embolia pulmonar presunta o confirmada, rotura cardíaca, insuficiencia cardíaca o infarto de miocardio recurrente [p. ej., trombosis remota o de endoprótesis] y muertes debidas a los procedimientos para tratar estos episodios cardíacos definidos) o un episodio de insuficiencia cardíaca hasta el mes 12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
through month 12 |
hasta el mes 12. |
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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 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 through Month 12 •Serum troponin T at Day 3 |
• Proporción de sujetos con muerte por cualquier causa o un episodio de insuficiencia cardíaca hasta el mes 12. • Número total de episodios cardiovasculares, definidos como muertes de origen cardiovascular y episodios de insuficiencia cardíaca hasta el mes 12. • Proporción de sujetos que presenten episodios cardiovasculares no mortales especificados de accidente cerebrovascular (ACV) tromboembólico, aneurisma o hemorragia ventricular, infarto de miocardio recurrente (p. ej., trombosis remota o de endoprótesis) o arritmia persistente, hasta el mes 12. • Concentración sérica de troponina T el día 3. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
see E.5.2 for evaluation timing |
ver E.5.2 para el tiempo de evaluación |
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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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
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 |
Czechia |
Germany |
Hungary |
Israel |
Italy |
Netherlands |
Poland |
Portugal |
Slovakia |
Spain |
United Kingdom |
United States |
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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 |