E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myocardial Infarction |
Infarto Agudo de Miocardio |
|
E.1.1.1 | Medical condition in easily understood language |
Myocardial Infarction |
Infarto Agudo de Miocardio |
|
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 | 19.0 |
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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-To compare the platelet aggregation at 30 minutes after administration of intravenous loading dose AL against an oral aspirin loading . |
Comparar la inhibición de la agregación plaquetaria a los 30 minutos de la administración de dosis de carga de AL intravenoso frente a la administración de una carga oral de aspirina. |
|
E.2.2 | Secondary objectives of the trial |
- To compare platelet aggregation: basal hour, 4 hours and 24 hours after administration of both treatment groups . - To compare platelet reactivity throughout the time sequence in both treatment groups . - To assess the safety of the treatment administered. |
- Comparar la inhibición de la agregación plaquetaria basal y a la hora, las 4 horas y las 24 horas de la administración de ambos grupos de tratamiento. - Comparar la inhibición de la reactividad plaquetaria en toda la secuencia temporal en ambos grupos de tratamiento. - Evaluar la seguridad de los tratamientos administrados. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ?18 years - Patient with acute myocardial infarction with ST segment elevation. - Signed informed consent |
- Edad ?18 años - Paciente con un infarto agudo de miocardio con elevación del segmento ST, definido como un episodio de dolor torácico o síntomas equivalentes asociado a alteraciones características del ECG (elevación persistente del segmento ST ?1mm en el plano frontal ó ?2mm en el plano precordial en dos o más derivaciones contiguas, o bien la presencia de un bloqueo completo de rama izquierda de nueva aparición). - Firma del consentimiento informado |
|
E.4 | Principal exclusion criteria |
- Allergy to aspirin, lysine acetylsalicylate , clopidogrel, prasugrel or ticagrelor . - Blood dyscrasias , including a history of thrombocytopenia. - Recent Antiplatelet therapy ( < 14 days) , including aspirin, lysine acetylsalicylate , clopidogrel, prasugrel , ticagrelor , cilostazol , dipyridamole , ticlopidine or glycoprotein IIb / IIIa . - Chronic treatment with oral anticoagulants. - Active bleeding . - Recent history of stroke, transient ischemic attack or intracranial hemorrhage ( < 6 months prior to inclusion period ) . - Severe renal impairment , defined as glomerular filtration rate ( Cockroft -Gault formula ) < 30 mL / min . - Elevated transaminase > 2.5 times the normal limit . - Active Neoplasia . - Pregnancy and lactation. - Concomitant terminal disease . - Inclusion in another clinical trial . |
- Alergia a aspirina, acetilsalicilato de lisina, clopidogrel, prasugrel o ticagrelor. - Discrasias sanguíneas, incluido antecedentes de trombocitopenia. - Tratamiento antiplaquetario reciente (< 14 días), incluyendo aspirina, acetilsalicilato de lisina, clopidogrel, prasugrel, ticagrelor, cilostazol, dipiridamol, ticlopidina o inhibidores de la glicoproteína IIb/IIIa. - Tratamiento crónico con anticoagulantes orales. - Hemorragia activa. - Historia reciente de ictus, accidente isquémico transitorio o hemorragia intracraneal (< 6 meses previos al periodo de inclusión). - Insuficiencia renal severa, definida como filtrado glomerular (fórmula de Cockroft-Gault) < 30mL/min. - Elevación de transaminasas > 2,5 veces el límite normal. - Neoplasia activa. - Gestación o lactancia. - Enfermedad terminal concomitante. - Inclusión en otro ensayo clínico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Platelet reactivity |
Reactividad plaquetaria analizada mediante agregometría por electrodos múltiples a los 30 minutos de la administración de los fármacos del estudio |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Platelet Reactivity. - Inhibition of platelet reactivity (IRP ). - Incidence of adverse events. |
- Reactividad plaquetaria analizada mediante agregometría por electrodos múltiples basalmente, a la hora, 4 horas y 24 horas de la administración de la medicación del estudio. - Inhibición de la reactividad plaquetaria (IRP) en toda la secuencia temporal. - Incidencia de acontecimientos adversos. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline , at the time , 4 hours and 24 hours after administration of study medication . |
base, 4 h y 24 h tras el 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 | 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 | Yes |
E.8.1.3 | Single blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 2 |
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
|
LVLP |
ultima visita ultimo paciente |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |