E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST-elevation myocardial infarction |
Infarto de miocardio con elevación del segmento ST |
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E.1.1.1 | Medical condition in easily understood language |
Heart attack |
Ataque cardíco |
|
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 | 10064345 |
E.1.2 | Term | ST segment elevation myocardial infarction |
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 evaluate the effect of MEDI6012 on infarct size compared with placebo. |
Evaluar el efecto de MEDI6012 en el tamaño del infarto en comparación con placebo. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of MEDI6012 on LV systolic function compared to placebo. 2. To evaluate the effect of MEDI6012 on non-calcified coronary plaque regression/progression from baseline to 10-12 weeks compared with placebo. 3. To evaluate the effect of MEDI6012 on remodeling of the LV measured by myocardial mass and volumes. 4. To evaluate the safety and tolerability of MEDI6012. 5. To describe the pharmacokinetics (PK) and immunogenicity of MEDI6012. |
1. Evaluar el efecto de MEDI6012 en la función sistólica VI en comparación con placebo. 2. Evaluar el efecto de MEDI6012 en la regresión/progresión de la placa ateromatosa coronaria no calcificada desde el periodo basal hasta las 10-12 semanas en comparación con placebo. 3. Evaluar el efecto de MEDI6012 en la remodelación del VI determinada mediante la masa miocárdica y los volúmenes. 4. Evaluar la seguridad y la tolerabilidad de MEDI6012. 5. Describir las propiedades farmacocinéticas (FC) y la inmunogenicidad de MEDI6012. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women without child-bearing potential aged 30-80 years of age who are capable and willing to provide informed consent. 2. Acute STEMI diagnosed by ST elevation (≥ 0.1 mV) in 2 contiguous leads 3. Planned for primary PCI 4. Ischemic symptoms for ≤ 6 hours 5. Capable of completing study visits |
1. Varones y mujeres que no tengan capacidad de procrear (para las definiciones, consúltese el apartado 10.2) y de 30 a 80 años que estén dispuestos a proporcionar un consentimiento informado y sean capaces de hacerlo. 2. IMEST agudo diagnosticado por la elevación del segmento ST (≥ 0,1 mV) en 2 electrodos contiguos. 3. Sujetos en los que está previsto realizar una ICP primaria. 4. Síntomas isquémicos de ≤ 6 horas de evolución. 5. Capaces de completar las visitas del estudio |
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E.4 | Principal exclusion criteria |
1. Pre-randomization cardiogenic shock or cardiopulmonary resuscitation 2. Fibrinolytic administration for index event 3. Known prior MI or prior coronary artery bypass grafting 4. Known pre-existing cardiomyopathy 5. History of anaphylaxis 6. Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy) 7. Other condition or severe illness that the investigator feels would limit the prognosis of the patient (eg, malignancy with life-expectancy < 3 months) or would make the patient otherwise unsuitable for enrollment (eg, pose a hazard or undue burden to the patient [known chronic renal or hepatic impairment, recent (< 30 days), cerebrovascular accident or transient ischemic attack] unable to complete study visits) 8. Known contraindication to MR imaging (eg, metallic implant, claustrophobia, implantable cardioverter-defibrillator (ICD), pacemaker, known eGFR<30 mL/min/1.73m2) 9. Pregnant women |
1. Choque cardiógeno o reanimación cardiopulmonar antes de la randomización. 2. Administración de fibrinolíticos para tratar el episodio inicial. 3.Antecedentes conocidos de IM o injerto de derivación coronaria. 4. Miocardiopatía preexistente conocida. 5. Antecedentes de anafilaxia. 6. Posible causa no trombótica (es decir, vasoespasmo, disección, miocardiopatía de Takotsubo) 7. Otra afección o enfermedad grave que, en opinión del investigador, limitaría el pronóstico del paciente (p. ej., neoplasia maligna con una esperanza de vida < 3 meses) o haría que el paciente, por cualquier otro motivo, no fuera apto para su inclusión (p. ej., supondría un riesgo o una carga excesiva para el paciente [disfunción renal o hepática crónica conocida, accidente cerebrovascular o accidente isquémico transitorio reciente (< 30 días)], incapaz de completar las visitas del estudio). 8. Contraindicación conocida a la RM (p. ej., implante metálico, claustrofobia, desfibrilador cardioversor implantable (DCI), marcapasos, FGe conocida < 30 ml/min/1,73 m2). 9. Mujeres embarazadas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Infarct size as a percentage of LV mass measured on delayed-enhanced (CV magnetic resonance [CMR]) imaging 10-12 weeks post-MI compared to placebo. |
Tamaño del infarto expresado como porcentaje de la masa VI medida mediante imágenes con contraste tardías de resonancia magnética CV (RMC) a las 10-12 semanas después del IM, en comparación con placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
10-12 weeks post myocardial infarction |
10-12 semanas después del Infarto de miocardio |
|
E.5.2 | Secondary end point(s) |
• EF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI compared to placebo. • Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI compared with placebo. • Myocardial mass and LV volumes at end-systole and end-diastole. • Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). • Lecithin-cholesterol acyltransferase (LCAT) mass and anti-drug antibodies (ADAs). |
• FE determinada mediante cine-resonancia magnética (cine-RM) a las 10-12 semanas tras el IM, en comparación con placebo. • Variación del VPNC en las arterias coronarias desde la angiotomografía computarizada (ATC) inicial hasta 10-12 semanas después del infarto, en comparación con placebo. • Masa del miocardio y volúmenes sistólico final y diastólico final del VI. • Incidencia de acontecimientos adversos surgidos durante el tratamiento (AAT) y de acontecimientos adversos graves (AAG) surgidos durante el tratamiento (AAGT). •Concentración de lecitina-colesterol aciltransferasa (LCAT) y anticuerpos antifármaco (AAF). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
10-12 weeks post myocardial infarction |
10-12 semanas después del Infarto de miocardio |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
paciente/MedImmune ciegos, investigador no ciego |
subject/MedImmune blinded, investigator unblinded |
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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 | 4 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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 |
Czech Republic |
Denmark |
Hungary |
Israel |
Netherlands |
Poland |
Russian Federation |
Slovakia |
Spain |
United Kingdom |
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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
|
The end of the study (“study completion”) is defined as the date of the last protocol-specified visit/assessment (including telephone contact) or death for the last subject in the study. |
El final del estudio se define como la fecha de la última visita/procedimiento especificado por el protocolo (incluyendo el contacto telefónico) o la muerte del último paciente en el estudio |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |