E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Paciente con indicación quirúrgica electiva de riesgo cardiovascular intermedio (cirugía oncológica con apertura del abdomen y/o tórax como, artroplastia de cadera o rodilla) y que esté recibiendo tratamiento habitual antiagregante como profilaxis secundaria: pacientes con diagnóstico previo de patologia cardiovascular. |
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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 | 10007648 |
E.1.2 | Term | Cardiovascular 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 |
Evaluar si la administración perioperatoria de AAS a bajas dosis no modifica la morbilidad y/o la mortalidad postoperatorias en cirugía programada de riesgo cardiovascular intermedio |
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E.2.2 | Secondary objectives of the trial |
Análisis de la estancia hospitalaria postoperatoria, porcentaje de ingresos y tiempo de estancia en la unidad de cuidados intensivos, e índice de reingresos hospitalarios. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Mayores de 18 años. No hay límite superior de edad. - Serán candidatos a inclusión en este ensayo todo/a paciente con indicación quirúrgica electiva de riesgo cardiovascular intermedio (cirugía oncológica con apertura del abdomen y/o tórax como, artroplastia de cadera o rodilla) y que esté recibiendo tratamiento habitual antiagregante como profilaxis secundaria: pacientes con diagnóstico previo de accidente isquémico cerebral transitorio, ictus establecido, afectación asistomática de troncos supraaórticos (estenosis de arteria carótida y/o vertebral igual o superior al 70%), arteriopatía obliterante de extremidades inferiores, antecedente de angina estable, inestable, infarto de miocardio, con/sin revascularización coronaria quirúrgica o percutánea. |
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E.4 | Principal exclusion criteria |
- Alergia al AAS - Edad: menores de 18 años. - Diagnóstico concomitante de plaquetopenia, (recuento plaquetario < 50*103/mm3) - Diagnóstico concomitante de plaquetopatía, - Diagnóstico concomitante de diátesis hemorrágica de cualquier etiología, - Diagnóstico concomitante de hepatopatía crónica, -- Diagnóstico concomitante de insuficiencia renal crónica: O aclaramiento de creatinina < 80 ml/min) y/o O creatinina sérica > 2.0 mgr/dL - Hipoalbuminemia severa de cualquier etiología, (Albuminemia < 3.0 gr/dL.) - Tratamiento habitual anticoagulante / tratamiento perioperatorio con heparina a dosis terapéuticas por cualquier causa, y - Tratamiento habitual antiagregante como profilaxis primaria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Son las ?complicaciones cardiovasculares? entendidas como todo episodio postoperatorio con diagnóstico (clínico, radiológico, ecografico, electrocardiográfico, y/o analítico) de isquemia cerebral, miocárdica (infarto agudo, angina), intestinal, renal, o de extremidades. |
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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 | 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 | 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 | 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.8.3 |
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 | 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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Control a los 90 día postintevención quirurgica |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |