E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
myocardial infarction, STEMI patients planned for Percutaneous Coronary Intervention |
infarto de miocardio, pacientes con IMEST planeados para Intervención coronaria percutánea |
|
E.1.1.1 | Medical condition in easily understood language |
heart disease, cardiovascular disease |
infarto de miocardio, enfermedades cardiovasculares |
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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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
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 efficacy of pre-hospital vs. in-hospital initiation of ticagrelor therapy by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a ?70% ST-segment elevation resolution pre-PCI |
Evaluar la eficacia del tratamiento con ticagrelor con inicio prehospitalario frente a hospitalario, comparando el porcentaje de pacientes que alcanzan el Endpoint coprincipal de flujo TIMI de grado 3 del vaso responsable del IM en la angiografía inicial o una resolución >/= 70% de la elevación del segmento ST antes de la ICP. |
|
E.2.2 | Secondary objectives of the trial |
?Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during 30 days of treatment ?Composite of death, MI, urgent revascularization during 30 days of treatment ?Acute stent thrombosis during 30 days of treatment ?Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI ?Complete (> 70%) ST-segment elevation resolution at 60 min post-PCI ?Corrected TIMI frame count, TIMI myocardial perfusion grade at angiography, pre and post PCI. ?Time?relationship (from symptom onset to 1st dose intake ) on each co-primary ?Time?relationship (from 1st dose intake to ECG/ angiography) on each co-primary ?TIMI flow grade 3 at end of procedure Assess the occurrence of major life-threatening bleeding events, other major bleeding events and minor or major bleeding events |
Comparar la eficacia del tratamiento con ticagrelor de inicio prehospitalario frente a hospitalario evaluando los siguientes criterios de valoración: Criterio combinado de muerte, IM, ictus, revascularización urgente y trombosis aguda del stent durante los 30 días de tratamiento Criterio combinado de muerte, IM, revascularización urgente durante los 30 días de tratamiento Trombosis aguda del stent durante los 30 días de tratamiento Tratamiento de rescate con inhibidores de GPIIb/IIIa en la ICP inicial Resolución completa (> 70%) de la elevación del segmento ST 60 min después de la ICP TIMI frame count corregido (cTFC) en la angiografía, antes y después de la ICP. Grado de perfusión miocárdica TIMI (TMPG) en la angiografía, antes y después de la ICP. Relación temporal (desde la aparición de los síntomas hasta la primera toma de dosis) en cada Endpoint coprincipal Relación temporal (desde la toma de la 1ª dosis al ECG/ angiografía) en cada Endpoint coprincipal |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adult men and women aged 18 years or older. Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
2. Symptoms of acute MI of more than 30 min but less than 6 hours
3. New persistent ST-segment elevation ? 1 mm in two or more contiguous ECG leads. |
1. Dar su consentimiento informado (formulario corto o versión completa del documento de consentimiento informado) en el entorno prehospitalario (véase la sección 8.4). Debido a la naturaleza de la enfermedad en estudio y al diseño del ensayo, el ECG de diágnostico se realizará en un entorno prehospitalario, como práctica habitual, antes de obtener el consentimiento informado de los pacientes. Estos datos se utilizarán para la evaluación de la elegibilidad para este ensayo. 2. Hombres y mujeres adultos de 18 años en adelante. Las mujeres no deben ser estar edad fértil (deben llevar más de 1 año desde la menopausia o ser quirúrgicamente estériles). 3. Síntomas de IM agudo de más de 30 minutos pero menos de 6 horas 4. Nueva Elevación persistente del segmento ST >/= 1 mm en dos o más derivaciones contiguas del ECG |
|
E.4 | Principal exclusion criteria |
1. Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes
2. Contraindication to ticagrelor (refer to SmPC)
3. Concomitant medication that may increase the risk of bleeding [e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization]
4. Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin.
5. Patients who has received a loading dose for the index event or who are on chronic treatment of prasugrel, clopidogrel or ticagrelor (commercial pack) |
1. El tiempo estimado desde la realización del ECG hasta el 1er inflado del balón en la ICP en el hospital va a ser más de 120 minutos. 2. No se ha firmado la versión completa del documento de consentimiento informado antes de la primera toma de ticagrelor activo, 90 mg dos veces al día 3. Tratamiento concomitante oral o intravenoso con inhibidores potentes del citocromo P450 3A (CYP3A) que no pueden suspenderse durante el curso del estudio 4. Contraindicación a ticagrelor (p. ej., hipersensibilidad al principio activo o a cualquiera de los excipientes, sangrado patológico activo, antecedentes de sangrado intracraneal previo, insuficiencia hepática moderada a severa) 5. Pacientes que hayan recibido una dosis de carga de clopidogrel, prasugrel o ticagrelor (envase comercial) para el acontecimiento en curso o que está en tratamiento crónico con prasugrel, clopidogrel o ticagrelor (envase comercial) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a ?70% ST-segment resolution pre PCI (co-primary endpoint) |
La proporción de pacientes que alcanzan un flujo TIMI 3 del grado 3 en el vaso relacionado con el IM en la angiografía inicial o una resolución de la elevación del segmento ST >/= 70% antes de la ICP. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
between baseline and PCI |
Entre el baselin y la ICP |
|
E.5.2 | Secondary end point(s) |
1. Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis
2. Percentage of patients presenting an acute stent thrombosis episode
3. Bleeding events a) The total number of patients with major life-threatening bleeding events b) Total number of patients with other major bleeding events, c) Total number of patients with minor or major bleeding events |
1. Porcentaje de pacientes en los siguientes casos: combinación de muerte, infarto de miocardio, ictus, revascularización urgente y trombosis aguda.
2. Porcentaje de pacientes que presentan un episodio de trombosis aguda
3. Episodios hemorrágicos a) El número total de pacientes con grandes hemorragias que amenazan la vida b) El número total de pacientes con otros eventos de sangrado mayor. c) El número total de pacientes con eventos mayores o menores de sangrado |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. during the 30 days of treatment
2. during the 30 days of treatment
3. within the first 48 hours and during 30 days of treatment |
1. durante los 30 días de tratamiento 2. durante los 30 días de tratamiento 3. dentro de las primeras 48 horas y durante los 30 días de tratamiento |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | 3 |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 20 |
E.8.9.2 | In all countries concerned by the trial days | 0 |