E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Profilaxis antiagregante en pacientes con cardiopatía isquémica estable |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008937 |
E.1.2 | Term | Chronic ischemic heart disease, unspecified |
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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 |
Evaluación del tiempo de oclusión del poro de membrana tras provocar la formación de un tapón plaquetario por activación y agregación de las plaquetas mediante el analizador de la función plaquetaria PFA-100 (Dade Behring |
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E.2.2 | Secondary objectives of the trial |
Seguriadad del tratamiento y correlación con otros parámetros clínicos y analíticos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
·Pacientes de ambos sexos mayores de 18 años. ·Diagnóstico de cardiopatía isquémica estable, en tratamiento con AAS y que hayan presentado no–respuesta al AAS tras 2 controles por PFA-100. ·Aceptación libre de participar en el ensayo, con consentimiento informado por escrito del paciente. ·Para mujeres en edad fértil: uso de medidas anticonceptivas adecuadas.
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E.4 | Principal exclusion criteria |
·Toma de ticlopidina, dipiridamol, clopidogrel u otros antiagregantes en los 14 días previos o durante el estudio. ·Administración de heparina 24 horas antes de su inclusión o durante el estudio. ·Toma de antiinflamatorios no esteroideos o ISRS en los 14 días previos o durante el estudio. ·Cirugía mayor 1 semana antes de su inclusión ·Paraproteinemías malignas ·Historia personal o familiar de alteraciones hemorrágicas ·Contaje plaquetario < 150x103 ml ó > 450 x 103 ml ·Hemoglobina < 8 g/dl ·Historia de desórdenes mieloproliferativos ·Historia de trombocitopenia inducida por heparina ·Alteraciones hepáticas o renales graves. ·Embarazo
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluación del tiempo de oclusión del poro de membrana tras provocar la formación de un tapón plaquetario por activación y agregación de las plaquetas mediante el analizador de la función plaquetaria PFA-100 (Dade Behring) |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |