E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with carotid stenosis undergoing angioplasty with stent implantation |
PAZIENTI CON STENOSI CAROTIDEA SOTTOPOSTI AD ANGIOPLASTICA CON IMPIANTO DI STENT |
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E.1.1.1 | Medical condition in easily understood language |
Patients with carotid stenosis undergoing angioplasty with stent implantation |
PAZIENTI CON STENOSI CAROTIDEA SOTTOPOSTI AD ANGIOPLASTICA CON IMPIANTO DI STENT |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10047065 |
E.1.2 | Term | Vascular disorders |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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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 |
Evaluate the effectiveness of various pharmacologic regimens with - Effect on the 24 hours of new cerebral ischemic events ipsilateral to carotid artery treated, as manifested in the post-nuclear magnetic resonance detectable PTA or after the procedure by increasing serum levels of NSE or SB100 |
Valutare l’efficacia di diversi regimi terapeutici farmacologici con - Incidenza a 24 ore di nuovi eventi ischemici cerebrali omolaterali alla carotide trattata, evidenziabili alla risonanza magnetica nucleare post-PTA o evidenziabili mediante aumento dopo la procedura dei valori sierici di SB100 o NSE |
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E.2.2 | Secondary objectives of the trial |
-30 |
- Incidenza a 30 giorni di stroke (definito come deficit neurologico della durata >24 ore con evidenza alla RM di lesione ischemica cerebrale) o TIA. - Incidenza di sanguinamenti maggiori e minori (definizione TIMI)20, e di complicanze vascolari in sede di accesso (ematomi, pseudoaneurismi, fistole AV). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
symptomatic or asymptomatic patients with reflected economic colordoppler angioTAC and carotid vascular disease of significant (> 70% diameter reduction according to the NASCET criteria or characteristics velocimetric) |
pazienti sintomatici o asintomatici con riscontro eco-colordoppler ed angioTAC di vasculopatia carotidea significativa (>70% di riduzione del diametro secondo i criteri NASCET o per caratteristiche velocimetriche) |
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E.4 | Principal exclusion criteria |
- Patients with recent ischemic stroke and / or presence of acute injury / subacute MRI of the brain. - Patients with active bleeding or with contraindications taking dual antiplatelet therapy - Patients with contraindications to statin therapy for history of severe liver disease, muscle diseases, or otherwise elevated baseline transaminase or CK - Patients with contraindications to MR examination (pacemaker / claustrophobic). |
- Pazienti con recente ictus ischemico e/o presenza di lesioni acute/subacute alla RM dell’encefalo. - Pazienti con sanguinamento in atto o comunque con contro-indicazioni all’assunzione di doppia terapia antiaggregante - Pazienti con controindicazioni alla terapia con statine per storia di grave epatopatia, malattie muscolari, o comunque elevati valori basali di transaminasi o di CK - Pazienti con controindicazioni all’esame RM (portatori di pacemaker/claustrofobici). |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Effect on the 24 hours of new cerebral ischemic events ipsilateral to carotid artery treated, as manifested in the post-nuclear magnetic resonance detectable PTA or after the procedure by increasing serum levels of NSE or SB100 |
- Incidenza a 24 ore di nuovi eventi ischemici cerebrali omolaterali alla carotide trattata, evidenziabili alla risonanza magnetica nucleare post-PTA o evidenziabili mediante aumento dopo la procedura dei valori sierici di SB100 o NSE |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- 30-day incidence of stroke (defined as a neurological deficit lasting> 24 hours with evidence of ischemic lesion on MRI brain) or TIA. - Incidence of major and minor bleeding (TIMI) 20, and vascular access site complications (hematoma, pseudoaneurysm, AV fistula). |
- Incidenza a 30 giorni di stroke (definito come deficit neurologico della durata >24 ore con evidenza alla RM di lesione ischemica cerebrale) o TIA. - Incidenza di sanguinamenti maggiori e minori (definizione TIMI)20, e di complicanze vascolari in sede di accesso (ematomi, pseudoaneurismi, fistole AV). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |