E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ischaemic stroke or transiet ischaemic attack |
Ictus ischemico o attacco ischemico transitorio |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10043647 |
E.1.2 | Term | Thrombotic stroke |
E.1.2 | System Organ Class | 10029205 - Nervous system 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 demonstrate the superiority of S 18886 30 mg o.d. over aspirin 100 mg o.d., in reducing cerebrovascular and cardiovascular events of ischaemic origin (primary efficacy end point: composite of ischaemic stroke, myocardial infarction, other vasculare death) in patients with a history of ischaemic stroke or transiet ischaemic attack. |
Dimostrare la superiorita'di S 18886 30 mg/die verso aspirina 100 mg/die nella riduzione degli eventi cerebro- e cardiovascolari di origine ischemica sul principale end point combinato: ictus ischemico, infarto del miocardio, altra morte vascolare, in pazienti con storia di ictus ischemico(IS) o attacco ischemico transitorio (TIA) |
|
E.2.2 | Secondary objectives of the trial |
to asses the effects of S 18886 on the other efficacy endpoints and its safety, as well as on prevention of cognitive decline and dementia. |
valutare gli effetti di S 18886 sugli altri endpoints di efficacia,la sua sicurezza e la prevenzione del declino cognitivo e della dementia. |
|
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 |
PHARMACOKINETIC/PHARMACODYNAMIC: Vers: Date: Title: Objectives:
LIFE QUALITY: Vers: Date: Title: Objectives:
|
FARMACOCINETICA/FARMACODINAMICA: Vers: Data: Titolo: Obiettivi:
QUALITA DELLA VITA: Vers: Data: Titolo: Obiettivi:
ALTRI SOTTOSTUDI: Valutazione degli effetti vascolari ( spessore intima media, insorgenza di placche, rigidita' arteriosa locale)
Biomarkers
MRI
|
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E.3 | Principal inclusion criteria |
Women or men, age superior or ugual 55 years,- Ischaemic stroke (IS) or arterial retinal ischaemic event (ARIE) confirmed by an optalmologist, > 48 hours and < 3 months before randomisation,- Or transiet ischaemic attak (TIA) with at least symptoms of motor weakness and/or aphasia, inferior or equal to 8 days before randomisation,- Neurologiacally, clinically and haemodynamically stable at inclusion,- All patients (IS/ARIE and TIA), having had a Computerised Tomography-scan (CT-scan) or a Magnetic esonance Imaging (MRI) ruling out intracranial haemorrhage or any non-ischaemic neurological disease,- Guiving informed consent |
Pazienti di ambo i sessi, con eta' superiore o uguale a 55 anni; ictus ischemico (IS) o evento ischemico dell'arteria retinica (ARIE), avvenuto piu' di 48 h e meno di 3 mesi prima della randomizzazione e confermato da oculista; o TIA negli 8 giorni precedenti la randomizzazione con sintomi di debolezza motoria e/o afasia; Stabilita' neurologica, clinica ed emodinamica all'inclusione; tutti i pazienti (IS/ARIE e TIA) avranno effettuato una CT-scan o una MRI per escludere emorragia intracranica o qualsiasi malattia neurologica di origine non ischemica;
Consenso informato |
|
E.4 | Principal exclusion criteria |
Cognitive impairment interfering with the possibility of obtaining patient's informed consent and/or with the conduct of the study,- Known dementia,- Pregnancy, breastfeeding or possibility of becoming pregnant during the study,- Criteria related to the qualifying event or other current medical conditions (detailed in the study protocol),- Crieria related to bleeding risk (detailed in the study protocol),- Criteria related to treatments (detailed in the study protocol) |
Alterazioni cognitive che interferiscono con la condotta dello studio e la possibilita' di ottenere il consenso informato; noto stato di demenza; gravidanza, allattamento o possibilita' di avere una gravidanza nel corso dello studio; criteri relativi all'evento qualificante o ad altre condizioni cliniche (dettagliati nel protocollo); criteri relativi al rischio di sanguinamento, dettagliati nel protocollo; criteri reltivi ai trattamenti, dettagliati nel protocollo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
First occurence of an event in the composite of ischaemic stroke, myocardial infarction, other vascular death (excluding haemorrhagic death of any origin). |
primo avvenimento di un evento combinato di ictus ischemico, infarto del miocardio, altra morte vascolare (esclusa morte per emorragia di altra origine) |
|
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 | No |
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 | 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 | 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) | 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 | 69 |
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 | Information not present in EudraCT |
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
|
Event driven trial: Ultima visita dell'ultimo paziente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |