E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stroke. Ischemic Stroke.
Ictus. Ictus isquémico. |
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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 | 10055221 |
E.1.2 | Term | Ischemic stroke |
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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 |
Demostrar que en la fase aguda del ictus isquémico el tratamiento con Simvastatina administrado en las primeras 12h del inicio de los síntomas mejora la situación neurológica y funcional del paciente valorado a los 7 días y tercer mes del inicio del tratamiento.
[To demonstrate that in the acute phase of ischemic stroke, Simvastatin given within 12 hours of stroke onset improves neurological and functional status evaluated at day seven (or at discharge if this occurs before day 7) and at three months respectively]. |
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E.2.2 | Secondary objectives of the trial |
Demostrar que la combinación de Simvastatina y t-PA en pacientes que han sufrido un ictus es segura y no presenta mayores tasas de Transformación Hemorrágica que el tratamiento con t-PA.
[To demonstrate that the combination of Simvastatin+tPA among patients who suffer a stroke is safe and do not has higher rates of hemorrhagic transformations than t-PA alone] |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Pacientes mayores de 18 años, diagnosticados de ictus isquémico de <12 horas de evolución.
2) Sospecha de afectación del territorio ACM-ACA-ACP
3) Pacientes con una puntuación de 4-22 en la Escala NIH.
4) Pacientes con una puntuación histórica estimada de 0 a 1 en la Escala de Rankin modificada.
5) Pacientes que hayan dado previamente su consentimiento informado sobre la participación en el estudio (paciente o representante).
6) Pacientes que no hayan recibido tratamiento con estatinas en los últimos seis meses.
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E.4 | Principal exclusion criteria |
1) Pacientes menores de 18 años.
2) Mujeres embarazadas o en periodo de lactancia.
3) Pacientes con evidencia clínica o mediante TC, realizado al ingreso, de hemorragia cerebral, infarto hemorrágico o lesión cerebral expansiva (neoplasia, absceso...)
4) Pacientes con crisis comiciales en el momento de la inclusión.
5) Pacientes que presenten resolución completa o sustancial de los síntomas antes de la aleatorización.
6) Pacientes con déficits neurológicos focales ipsilaterales que pudieran dificultar la evaluación del déficit neurológico actual.
7) Pacientes con hepatopatía (AST o ALT> 2 veces límite superior normal [LSN]).
8) Pacientes con disfunción renal severa o síndrome nefrótico.
9) Pacientes con shock cardiogénico o insuficiencia cardiaca congestiva relevante.
10) Pacientes con CPK> 5 veces LSN.
11) Pacientes con hipoglicemia concurrente grave.
12) Pacientes que hayan presentado IAM u otro proceso tromboembólico, en los treinta dias previos.
13) Pacientes con un proceso infeccioso activo en el momento de la inclusión, tanto crónico (hepatitis B o C, TBC...), como agudo (procesos infecciosos de vías aéreas, urinarias, o digestivas).
14) Pacientes con hipersensibilidad documentada a los inhibidores de la HMG-CoA reductasa.
15) Pacientes con trastorno psiquiátrico concurrente importante, que pudiera intervenir en la evaluación neurológica.
16) Pacientes con cualquier otra enfermedad concomitante de importancia o en estadio terminal.
17) Pacientes con historial de abuso de drogas o alcohol.
18) Pacientes que no puedan acudir a todos los controles del estudio.
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E.5 End points |
E.5.1 | Primary end point(s) |
Porcentaje de pacientes independientes (escala de Rankin Modificada <3) al tercer mes. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |