E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non ST Elevation Acute Coronary Syndromes |
SINDROME CORONARICA ACUTA SENZA SOPRASLIVELLAMENTO DEL TRATTO ST |
|
E.1.1.1 | Medical condition in easily understood language |
Non ST Elevation Acute Coronary Syndromes |
SINDROME CORONARICA ACUTA SENZA SOPRASLIVELLAMENTO DEL TRATTO ST |
|
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 assess MP levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high acetyl-salicylic acid (ASA), in comparison with clopidogrel+ASA treatment, to demonstrate that major clinical efficacy of ticagrelor could be partially attributed to its influence on release of MP, that have an important role in coronary instability. |
Valutare la variazione nel tempo dei livelli ematici delle Microparticelle (MP) nei pazienti con Sindromi coronariche acute senza sopraslivellamento del tratto ST (Non-ST Elevation 10 Acute Coronary Syndrome -NSTE-ACS) trattati con ticagrelor in associazione all’acido acetilsalicilico (ASA), rispetto alla doppia terapia anti-aggregante costituita da clopidogrel e ASA, per dimostrare che la maggiore efficacia clinica del ticagrelor potrebbe essere parzialmente attribuita alla sua influenza sul rilascio di MP, le quali esercitano un ruolo importante nell’instabilità coronarica. |
|
E.2.2 | Secondary objectives of the trial |
- to evaluate microRNAs levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high ASA, in comparison with clopidogrel+ASA treatment, and to study possible correlation between microRNAs and MP levels, supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression. |
Valutare la variazione nel tempo dei livelli di microRNA nei pazienti con Sindromi coronariche acute senza sopraslivellamento del tratto ST (Non-ST Elevation Acute Coronary Syndrome -NSTE-ACS) trattati con ticagrelor in associazione all’acido acetilsalicilico (ASA), rispetto alla doppia terapia anti-aggregante costituita da clopidogrel e ASA, e studiare una possibile correlazione tra i livelli di microRNA e di MP, supponendo che la capacità del ticagrelor nel ridurre i livelli di MP potrebbe essere correlata con l'espressione di microRNA. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-PATIENT WITH NON-ST ELEVATION ACUTE CORONARY SYNDROMES - men aged between 50 and 80 years - postmenopausal women |
pazienti con sdr coronarica acuta senza sopraslivellamento del tratto ST. Uomini di età compresa tra 50 e 80 anni - Donne in età postmenopausale |
|
E.4 | Principal exclusion criteria |
men aged <50 years or >80 years - impossibility to give informed consent - women of childbearing age - diabetes mellitus - severe renal failure (CrCl < 30 ml/min) - infective, neoplastic or autoimmune diseases - ACS and /or TIA/stroke in the previous three months - trauma or surgical operations in the previous three months - active hemorrhage - fibrinolytic therapy within 24 hours before randomization, - a need for oral anticoagulation therapy - an increased risk of bradycardia - drugs study hypersensitivity (including aspirin) - moderate to severe hepatic impairment 15 - co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
GRACE RISK SCORE >140
In stent restenosis |
Uomini di età inferiore ai 50 anni o superiore agli 80 anni - Impossibilità a dare il consenso informato 12 - Donne in età fertile - Diabete mellito - Insufficienza renale cronica di grado severo (CrCl < 30 ml/min) - Malattie infettive, neoplastiche o autoimmuni - Sindromi coronariche acute e/o eventi cerebrovascolari nei tre mesi precedenti all’arruolamento - Trauma o interventi chirurgici nei tre mesi precedenti all’arruolamento - Emorragie attive - Terapia fibrinolitica nelle 24 ore precedenti all’arruolamento - Necessità di terapia anticoagulante orale - Aumentato rischio di bradiaritmie - Allergia/intolleranza ai farmaci coinvolti nello studio (inclusa l’aspirina) - Insufficienza epatica di grado moderato-severo - Somministrazione di potenti inibitori del citocromo CYP3A4 (es: ketoconazolo, claritromicina, nefazodone, ritonavir, e atazanavir)
pazienti con GRACE RISK SCORE elevato (>140)
Restenosi in stent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
MP levels variation |
dosaggio livelli MP |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
evaluate microRNAs levels |
dosaggio livelli microRNA |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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 | 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) | 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 | 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) | 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
| 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 24 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |