E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Coronary Syndrome |
Sindrome Coronarica Acuta |
|
E.1.1.1 | Medical condition in easily understood language |
Acute Coronary Syndrome |
Sindrome Coronarica Acuta |
|
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 | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
E.1.2 | System Organ Class | 10007541 - Cardiac 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 compare the effect of SAR236553 (REGN727) with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia |
L’obiettivo primario del presente studio consiste nel confrontare l’effetto di SAR236553 con placebo in relazione all’insorgenza di eventi cardiovascolari (endpoint composito di decesso per coronaropatia (CHD), infarto miocardico (MI) non fatale, ictus ischemico fatale e non fatale, angina instabile con necessità di ospedalizzazione) in pazienti con un episodio di sindrome coronarica acuta (ACS) insorto 4-16 settimane prima della randomizzazione e sottoposti a trattamento intensivo farmacologico e dietetico per il trattamento della dislipidemia. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of SAR236553 (REGN727) on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality). To evaluate the safety and tolerability of SAR236553 (REGN727). To evaluate the effect of SAR236553 (REGN727) on lipid parameters |
Valutare l’efficacia di SAR236553 rispetto al placebo sugli endpoint secondari (qualsiasi evento CHD, evento CHD importante, qualsiasi evento CV, insieme di tutte le cause di mortalità/IM non fatale/ictus ischemico non fatale, tutte le cause di mortalità). - Valutare la sicurezza e la tollerabilità di SAR236553. - valutare gli effetti d SAR236556 (REGN/727) sul profilo lipidico. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Recently hospitalized for ACS |
Ospedalizzazione recente per Sindrome Coronarica Acuta |
|
E.4 | Principal exclusion criteria |
Age < 40 years. - ACS event occurring more than 16 weeks prior to randomization visit. o LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia |
Età < 40 anni. - Sindrome Coronarica Acuta insorta più di 16 settimane prima della visita di randomizzazione. - Colesterolo LDL <70mg/dL (<1.81 mmo/L)con terapia farmacologica e dietetica per per il trattamento della dislipidemia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time from randomization to first occurrence of one of the following Clinical Events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization |
• Tempo dalla randomizzazione alla prima insorgenza di uno dei seguenti eventi clinici, determinati dal CEC: - decesso per CHD - IM non fatale - ictus ischemico fatale o non fatale - angina instabile con necessità di ospedalizzazione |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to Month 64 |
Fino al mese 64 |
|
E.5.2 | Secondary end point(s) |
Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality - Change from baseline in blood lipids and lipoprotein levels - Number of patients with adverse events |
Tempo al verificarsi di qualsiasi evento CHD, evento CHD maggiore, qualsiasi evento cardiovascolare. Endpoint composito di mortalità per qualsiasi causa, IM non fatale, stroke ischemico non fatale, morte per ogni causa.
Variazione dal basale del profilo lipidico nel sangue. Numero di pazienti con eventi avversi |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to Month 64 |
Fino al Mese 64 |
|
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 410 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belarus |
Brazil |
Canada |
Chile |
China |
Colombia |
Hong Kong |
India |
Israel |
Korea, Democratic People's Republic of |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Peru |
Philippines |
Russian Federation |
Singapore |
South Africa |
Switzerland |
Taiwan |
Thailand |
Turkey |
Ukraine |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
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 | 6 |
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 |