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 cardiac ischemia |
ischemia acuta del miocardio |
|
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 | 15.0 |
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 |
comparing reduced-dose prasugrel and standard dose clopidogrel with regard to the primary endpoint of the study |
Confrontare prasugrel a dose ridotta e clopidogrel a dose standard rispetto all’endpoint primario dello studio |
|
E.2.2 | Secondary objectives of the trial |
To assess the prognostic impact of selected pre-randomization variables |
Valutare l’impatto prognostico di variabili selezionate presenti al basale |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 48 hours, and candidates to an early PCI.
Patients must be able to provide written informed consent before randomization. |
Pazienti di età >74 anni ospedalizzati per sindrome coronaria acuta, con o senza STE, con un inizio di sintomi durante le precedenti 48 ore, e candidati ad una PCI primaria.
I pazienti devono inoltre essere i grado di fornire un consenso informato scritto prima della randomizzazione. |
|
E.4 | Principal exclusion criteria |
• History of stroke or TIA
• Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
• Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known mielodysplasia.
• Secondary causes of acute myocardial ischemia.
• Known current platelet count < 90,000 cells/L.
• Ongoing oral anticoagulant treatment or an INR known to be >1.5 at the time of screening.
• Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
• Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization
• Inhability to give at least verbal informed consent to the study.
. Contraindications to the use of clopidogrel or prasugrel as per package leaflet |
• Storia clinica di ictus o attacco ischemico transitorio (TIA)
• Sanguinamenti gastrointestinali o genitourinari clinicamente significativi entro le 6 settimane antecedenti la randomizzazione
• Livelli di emoglobina al ricovero < 10g/dl, a meno che questo non sia secondario ad una disfunzione renale o ad una mielodisplasia già nota
• Cause secondarie di ischemia miocardica acuta
• Già noto numero delle piastrine <90000cell/L
• Trattamento anticoagulante per via ora in corso oppure un INR noto >1.5 al momento dello screening
• Concomitante patologia ostruttiva polmonare severa, neoplasie o deficit neuronali che limitano i follow-up e l’aderenza al protocollo di studio
• Partecipazione a qualsiasi fase di altri studi clinici che coinvolgono la valutazione di un altro farmaco o dispositivo medico entro i 30 giorni prima della randomizzazione
• Incapacità di fornire anche un consenso informato verbale allo studio
• Controindicazioni all’uso di clopidogrel o prasugrel come riportato sul foglietto illustrativo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year. |
Endpoint composito di morte per qualsiasi causa, (re)infarto del miocardio, ictus disabilitante e ri-ospedalizzazione per cause cardiache o per sanguinamenti entro un anno dalla randomizzazione. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 12 months |
fino a 12 mesi |
|
E.5.2 | Secondary end point(s) |
• The burden (global occurrence) of recurrent cardiovascular events
• Cardiovascular mortality at one year
• All-cause mortality and myocardial (re)infarction at 1 year
• Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 12 months (for bleedings occurring during index or subsequent hospitalizations)
• BARC type IV bleeding within one year
• Any stroke within 12 months
• Total number of days spent in hospital within 12 months after index admission. |
• L’impatto delle recidive di eventi cardiovascolari ad un anno
• La mortalità cardiovascolare ad un anno
• Le morti per qualsiasi causa e i re(infarti) del miocardio ad un anno
• I sanguinamenti di tipo BARC 2 o 3 nei 12 mesi (per i sanguinamenti che avvengono durante l’ospedalizzazione iniziale o durante successive ospedalizzazioni)
• Sanguinamenti di tipo BARC IV nel corso di un anno
• Tutti gli ictus nel corso dei 12 mesi
• Numero totale di giorni di ricovero nei 12 mesi successivi alla dimissione iniziale |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to 12 months |
fino a 12 mesi |
|
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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
stratificato per tipo di infarto |
stratified |
|
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 | 34 |
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
|
Enrolment will be stopped when the predefined number of 492 adjudicated events will be reached. The study will be closed when the last enrolled patient will have completed 3 month follow up. |
L'arruolametno sarà chiuso al raggiungimento di 492 eventi aggiudicati (studio "event-driven") e lo studio teminerà quando l'ultimo paziente arruolato avrà completato 3 mesi di follow-up |
|
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 | 36 |
E.8.9.1 | In the Member State concerned days | 0 |