E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute coronary syndromes without persistent ST-segment elevation |
Pazienti affetti da sindrome coronarica acuta senza sopraslivellamento persistente del tratto ST-T |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with acute heart attack |
Pazienti con attacco cardiaco acuto |
|
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 |
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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 |
The aim of the present study is to assess the level of platelet inhibition associated with switching a group of intermediate-to-high NSTEACS patients from the standard clopidogrel treatment (up to LD 600/75 mg MD) to 3 different switching strategies using different prasugrel dosage. |
L'obiettivo del presente studio è quello di valutare 3 diverse strategie di “switching” a prasugrel, sotto il profilo farmacodinamico (il livello di inibizione piastrinica). |
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E.2.2 | Secondary objectives of the trial |
Evaluation of clinical safety in terms of death, reinfarction and major bleeding. |
Valutazione di sicurezza clinica in termini di morte, reinfarto e sanguinamenti maggiori. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 year old with typical chest pain lasting >30 min and at least one of the following features: ST-segment shift >1 mV in 2 adjacent ECG leads and/or the presence of negative T-waves (3 mm depth) or the isolated elevation of cardiac troponin T. |
Età > 18 anni con dolore toracico tipico della durata > 10 min e almeno una delle seguenti caratteristiche: sopra-livellamento transitorio o sotto-livellamento segmento ST => 1 mV in 2 derivazioni ECG contigue e/o la presenza di onde di T negative (=>3 mm di profondità) o l'elevazione della troponina cardiaca T (TnT). |
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E.4 | Principal exclusion criteria |
Any prior thienopyridine treatment, planned “upstream treatment” with IIB/IIIA intravenous receptor blockers (GPI), need for chronic oral anticoagulation, recent fibrinolytic administration, increased bleeding risk or anaemia. We will also exclude patients with body weight 60 kg and/or 75 yrs old patients ( to exclude patients indicated for 5 mg MD which would introduce further noise into pharmacodynamic comparison due to the small numbers of observations) and patients with a previous history of TIA/stroke (contraindicated). |
Pazienti già in terapia con tienopiridine, pretrattamento con inibitori delle glicoproteine GPIIB/IIIA, pazienti in terapia cronica con anticoagulanti orali, recente somministrazione di fibrinolitici, aumentato rischio di emorragia o anemia. Saranno anche esclusi i pazienti con peso corporeo <60 kg e/o >75 anni (per evitare i pazienti con indicazione a 5 mg MD che introdurrebbero ulteriori difficoltà di confronto a causa di un esiguo numero del campione) e pazienti con una storia precedente di TIA/ictus (controindicato). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference of residual platelet reactivity index (VASP) at 4 hours after randomization as compared with the level showed at the time of blood sample taken immediately before diagnostic catheterization (baseline 2 sample), between the group of patients switched to prasugrel LD of 60 mg /MD 10 mg and the group of patients kept on clopidogrel MD. |
La differenza di indice di reattività (PRI del metodo VASP) 4 ore dopo la randomizzazione rispetto al livello mostrato al momento immediatamente prima della coronarografia (campione baseline 2), tra il gruppo A di pazienti “passati” a prasugrel (LD 60 mg e MD 10 mg) rispetto al gruppo di pazienti che sono stati mantenuti in trattamento con clopidogrel (Gruppo D o di controllo). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 hours after randomization |
4 ore dopo la randomizzazione |
|
E.5.2 | Secondary end point(s) |
1) Comparison of different prasugrel dosages among themselves and with clopidogrel in terms of PRI 2) Comparison of different prasugrel dosages among themselves and with clopidogrel in terms of PRU 3) Comparison of different prasugrel dosages among themselves and with clopidogrel in terms of PFA-100 parameters (time closure) |
1) confronto dei diversi dosaggi di prasugrel con clopidogrel e tra loro in termini di PRI (metodo VASP) 2) Confronto dei diversi dosaggi di prasugrel con clopidogrel e tra loro in termini di PRU (metodo Verify-Now) 3) Confronto dei diversi dosaggi di prasugrel con clopidogrel e tra loro in termini di parametri PFA-100 (tempo chiusura) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Same timepoint as for the primary end point |
Uguale ad end point primario |
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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 | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
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 |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | 0 |