E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplasty |
Pacientes con infarto agudo de miocardio con elevacion de ST programados para angioplastia primaria |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with an acute myocardial infarction, scheduled for emergency coronary angioplasty |
Pacientes con infarto agudo de miocardio que se van a someter a angioplastia primaria |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066641 |
E.1.2 | Term | Acute myocardial infarction, of anterior wall |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068109 |
E.1.2 | Term | Anterolateral myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000918 |
E.1.2 | Term | Acute myocardial infarction, of other specified sites, initial episode of care |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028596 |
E.1.2 | Term | Myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066673 |
E.1.2 | Term | Transmural myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067273 |
E.1.2 | Term | Acute transmural myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
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 | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028597 |
E.1.2 | Term | Myocardial infarction acute |
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 |
The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously and additional a second bolus of 5 mg in cathlab before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to undergo primary PCI (PCI) |
El objetivo primario de este estudio randomizado es determinar los efectos beneficiosos en el tamaño del infarto por la administración temprana de 5 mg de metoprolol intravenoso y un segundo bolo adicional de 5 mg al llegar al hospital antes de la reperfusión, en pacientes con infarto agudo de miocardio, con elevacion de ST y que van a ser sometidos a angioplastia primaria |
|
E.2.2 | Secondary objectives of the trial |
Troponin-T after 24 hour of hospitalization Peak CK within hospitalization period Area under CK and CK-MB curve within hospitalization period. Residual ST deviation 1 hr after CAG/PCI Ventricular Fibrillation requiring defibrillation during transportation and hospitalisation MACE at 30 days and one year FUP Safety End Points The incidence of severe bradycardia, asthma or cardiogenic shock 30 day and one year total Mortality |
troponina-T despues de 24 horas de hospitalizacion Pico de CK en el periodo de hospitalización Area bajo la curva y CK-MB curva en el periodo de hospitalización Desviacion ST residual una hora depues de la angioplastia fibrilacion ventricular que requiere desfibrilación durante el transporte al hospital MACE a los 30 dias y al año de seguimiento Variables de seguridad La incidencia de bradicardia severa, asma o shock cardiogénico Mortalidad al mes y al año |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Zotarolimus eluting stent compared with GENOUS stent in patients with ST-elevation myocardial infarction undergoing primary PCI. |
stent recubierto de Zotarolimus comparado con stent GENOUS en pacientes con infarto de miocardio con elevación de ST sometidos a angioplastia primaria. |
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E.3 | Principal inclusion criteria |
Patients ? 18 years of age with symptoms of acute ST-elevation myocardial infarction of more than 30 min but less than 12 h and ST-segment elevation of more than 1 mV in two adjacent electrocardiograph (ECG) leads. |
Pacientes mayores de 18 años con síntomas de infarto agudo de miocardio con elevación de ST de más de 30 min de duración pero menos de 12 horas , y elevación de ST de mas de 1mV en dos derivaciones consecutivas |
|
E.4 | Principal exclusion criteria |
Severe Hypotension (systolic blood pressure 90 mmHg) Cardiogenic shock Severe Asthma Severe bradycardia (<50 bpm) Previous myocardial infarction Unable to provide informed consent |
hypotensión severa shock cardiogénico asma severa bradicardia severa infarto de miocardio previo no puede dar consentimiento informado |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Infarct size as measured by MRI. |
Tamaño del infarto medido por resonancia magnética |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month after the myocardial infarction |
Un mes después del infarto agudo de miocardio |
|
E.5.2 | Secondary end point(s) |
Troponin-T after 24 hour of hospitalization Peak CK within hospitalization period Area under CK and CK-MB curve within hospitalization period. Residual ST deviation 1 hr after CAG/PCI Ventricular Fibrillation requiring defibrillation during transportation and hospitalization MACE at 30 days and one year FUP |
Troponina-T después de 24 horas de hospitalización Pico de CK en el periodo de hospitalización Area bajo la curva de CK y cK-MB durante hospitalizacion Desviacion residual de ST una hora despues de la angioplastia primaria Fibrilación ventricular que requiere desfibrilación transporte y hospitalización MACE a los 30 dias y un año de seguimiento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Hospitalization and 30 day fup and one year fup |
hospitalización y seguimiento a los 30 días y un año |
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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 | No |
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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | Information not present in EudraCT |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |