E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST elevation myocardial infarction |
Infarto agudo de miocardio con elevación de ST |
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E.1.1.1 | Medical condition in easily understood language |
Myocardial infarction |
Infarto agudo de miocardio |
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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 | 17.1 |
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 |
The main objective is to investigate whether pharmacological treatment guided by the angiographic evidence of thrombus(intracoronary thrombolysis) in percutaneous coronary intervention is more effective than standard percutaneous coronary intervention (manual thrombectomy) in achieving an optimal epicardial and myocardial reperfusion to minimize the size of myocardial necrosis in the setting of acute ST elevation myocardial infarction. |
El objetivo principal es investigar si el tratatamiento farmacológico adyuvante guiado por la carga trombótica (trombolisis intracoronaria) en el tratamiento percutáneo es más eficaz que el tratamiento percutáneo estándar (trombectomía) en lograr una óptima reperfusion epicárdica y miocárdica para reducir el tamaño de la necrosis miocárdica en el infarto agudo de miocárdio con elevación del ST. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Chest pain suggestive of myocardial ischemia for at least 30 minutes -Symptoms onset less than 12 hours before hospital admission -ST segment elevation of at least 1 mm in two or more contiguous leads (>o = 2mm in precordial leads) -To understand and accept the study procedures and signed informed consent |
-Dolor torácico sugestivo de isquemia miocárdica durante al menos 30 minutos -Aparición de los síntomas de a lmenos de 12 horas antes de su ingreso hospitalario -Elevación del segmento ST de al menos 1mm en derivadas contiguas (al menos 2mm en derivadas precordiales) -Comprender y aceptar los procedimientos del estudio y firmar el consentimiento informado |
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E.4 | Principal exclusion criteria |
-ST elevation myocardial infarction presenting with cardiogenic shock -Previous myocardial infarction (< 6 months) -Formal contraindication to thrombolysis or to prasugrel -Patients on oral anticoagulation therapy -Patients treated with vitamin K, bivalirudin or fondaparinux -Patients with severe renal failure (glomerular filtration rate <30ml/min/m2) -Patients with contraindication to study medications, which cannot be managed medically, including: adenosine, heparin, IIb-IIIa inhibitors, contrast agents, clopidogrel, ticagrelor, prasugrel or aspirin -Known life-threatening disease with a life expectancy of <12 months -Inability to obtain informed consent -Patients with contraindications to cardiovascular magnetic resonance -Pregnant or breastfeeding patient -Allergic reaction to the product (Methylase) and/or excipient -Patients presenting with pace rhytm, preexcitation or other conditions or artifacts interfering with the interpretation of ST segment resolution -Patient presenting with second or third degree of atrioventricular block or need of temporal pacemarker -Culprit lesion located in small segments or secundary branches <2.5 mm diameter -Impossibility to advance thrombectomy/Amicath device due to extreme tortuosy or calcification -Significant left main disease -Thrombolysis in myocardial infarction (TIMI) flow 3 without the visualization of intracoronary thrombus at initial angiography |
-Infarto agudo de miocardio con elevacion del ST y situación de shock cardiogénico -Antecedentes de infarto agudo de miocardio en los 6 meses previos -Contraindicación a tratamiento trombolítico o al tratamiento con prasugrel: -Tratamiento activo con anticoagulantes orales -Tratamiento activo con antagonistas de la vitamina K, bivalirudina o fondoparinux -Filtrado glomerular renal por debajo de 30mL/min/m2 -Contraindicación a cualquiera de los medicamentos administrados en el estudio: adenosina, heparina, inhibidores IIb-IIIa, agentes de contraste, clopidogrel, ticagrelor, prasugrel o aspirina -Expectativa de vida inferior a 12 meses -Imposibilidad de obtener el consentimiento informado -Contraindicación para la realización de RMN -Mujeres embarazadas o en periodo de lactancia -Antecedentes de alergia, idiosincrasia, hipersensibilidad o reacciones adversas al principio activo o a cualquiera de los excipientes -Pacientes portadores de marcapasos, preexcitacion o alteraciones de la repolarización preexistentes que impidan la evaluación de la resolución del descenso del segmento ST -Trastornos del ritmo cardiaco que pudieran requerir estimulación cardiaca (bloqueo auriculoventricular de segundo o tercer grado) -Oclusión de arterias de pequeño tamaño (<2.5mm de diámetro) -Imposibilidad para avanzar los dispositivos tanto de trombectomía como de administración del fibrinolítico. -Enfermedad del tronco común -Infarto agudo de miocardio con elevación ST pero con flujo epicárdico normal y ausencia de trombo en la angiografía inicial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Necrotic myocardial volume (in mL/m2 and in % of LV mass) by contrast enhanced cardiovascular magnetic resonance |
Volumen necrótico miocárdico (mL/m2 y % de masa del VI) por realce tardío mediante resonancia magnética nuclear cardíaca |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Outcome measured during the first 7 days after the ST elevation myocardial infarction |
Variable mesurada durante los 7 primeros dias despues del infarto agudo de miocardio con elevación del ST |
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E.5.2 | Secondary end point(s) |
1.Microvascular obstruction as a dichotomic variable and as myocardial volume (in mL/m2 and as a % of left ventricle mass) 2.Salvage myocardium volume (as % of left ventricle mass) 3.Segmental transmurality (at least >50% of the transmural depth and at least 50% of the extension of the segment) 4.Rate of ST-segment resolution at 60 minutes after the completion of primary PCI 5.Post-procedural: TIMI flow grade (TFG) 6.Post-procedural TIMI BLUSH myocardial grade (TBG) and TIMI trombus grade (TTG) 7.TIMI bleeding events 8.Cardiac death 9.Combination of cardiac death and non-fatal re-infarction 10.Major cardiac events (MACE) 11.Stent thrombosis according to the ARC definitions 12. Measurament of residual thrombus by optical coherence tomography |
1.Obstrucción microvascular (mL/m2 y porcentaje de masa del ventriculo izquierdo) 2.Miocardio Salvado (porcentaje de masa del ventriculo izquierdo) 3.Numero de segmentos con transmuralidad superior al 50% 4.Resolución del descenso ST a los 60 minutos de la ICP 5.Reperfusión epicardica: TIMI flow grade (TFG) 6.Reperfusión miocárdica: TIMI BLUSH myocardial grade (TBG) y grado de trombo (TIMI trombus grade, TTG) 7.Tasa de complicaciones hemorrágicas 8.Muerte de causa cardíaca 9.Combinación de muerte de causa cardíaca y reinfarto 10.Eventos cardiacos mayores 11.Trombosis intrastent durante el seguimiento definida por la ARC 12. Cantidad de trombo residual por tomografía de coherencia optica |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints of evaluation of endpoints: 1-6, 12. after the procedure 7. during admission 8-10. during admission and at 30 days, 6 months and 12 months 11. during follow up (12 months) |
Momento de evaluación de las variables: 1-6. tras el procedmiento 7. durante el ingreso 8-10. durante el ingreso, a los 30 días, 6 meses y 12 meses 11. durante el seguimiento (12 meses) |
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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 | 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) | 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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Trombectomia (Intervención coronaria percutánea, ICP) |
Systematic manual thrombectomy (percutaneous coronary intervention, PCI) |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |