E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes and ST-elevation myocardial infarction treated with primary primary percutaneous coronary intervention and reduced left ventricle ejection fraction. |
Pazienti con diabete mellito di tipo 2 ed infarto miocardico acuto con sopraslivellamento del tratto ST trattati con angioplastica primaria e ridotta funzione ventricolare sinistra. |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetic patients with acute myocardial infarction and reduced cardiac function |
Pazienti con diabete ed infarto miocardico acuto trattato e ridotta funzionalità cardiaca |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064346 |
E.1.2 | Term | STEMI |
E.1.2 | System Organ Class | 100000004849 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011949 |
E.1.2 | Term | Decompensation cardiac |
E.1.2 | System Organ Class | 100000004849 |
|
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 |
We investigate te effect of an early use of the SGLT-2 inhibitor dapaglifozin in term of infarct size reduction (assessed by cardiac MRI) in diabetic patients admitted for ST-elevation myocardial infarction with low left ventricle ejection fraction. |
L'obiettivo dello studio è di analizzare l'effetto di un utilizzo precoce dell'inibitore SGLT-2 in termini di riduzione di del volume dell'infarto (misurata con risonanza magnetica cardiaca) in pazienti ricoverati per infarto miocardico acuto con ridotta funzione ventricolare sinistra. |
|
E.2.2 | Secondary objectives of the trial |
We will investigate potential cardioprotective effects of SGLT-2 inhibitor and to evaluate its safety |
Gli obiettivi secondary dello studio prevedono di valutare l'effetto cardioprotettivo e la sicurezza di inibitori SGLT-2 in pazienti diabetici con infarto miocardico acuto e ridotta frazione di eiezione del ventricolo sinistro. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Type 2 diabetes mellitus ST-elevate myocardial infarction Percutaneous coronary angioplasty <12 hours from symptom onset TIMI coronary flow 0-1 at the time of primary PCI Left ventricle ejection fraction 40% assessed within 12 hours from admission |
Diabete mellito di tipo 2 Infarto miocardico con sopralivellamento del tratto ST Angioplastica coronarica percutanea entro 12 ore dall'inizio dei sintomi Flusso TIMI 0-1 iniziale Frazione d'eiezione del ventricolo sinistro minore o uguale a 40% registrata entro 12 ore dall'ingresso |
|
E.4 | Principal exclusion criteria |
Cardiogenic shock Symptomatic hypotension History of restrictive cardiomyopathy, constrictive pericarditis, or untreated severe heart valve disease History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes Severe hepatic insufficiency Active cancer eGFR<30 ml/min |
Shock cardiogeno Ipotensione sintomatica Storia di cardiomiopatia restrittiva, pericardite costrittiva, o valvulopatia grave non trattata Storia di chetoacidosi diabetica, diabete secondaria o diabete di tipo 1 Insufficienza epatica grave Cancro attivo eGFR <30 ml/min |
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E.5 End points |
E.5.1 | Primary end point(s) |
Infarct size, as assessed by cardiac MRI |
Dimensione dell'infarto misurato con risonanza magnetica cardiaca |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Difference in the change of body weight; cardiovascular death or worsening heart failure; re-myocardial infarction, stroke or unplanned coronary revascularization; All-cause death; Duration of in-hospital stay; Arterial pressure values; Side effects; Cardiac features at MRI and echocardiography; Laboratory outcomes differences (B-type natriuretic peptide, Renal function, EPO, hematocrit) |
Cambio del peso corporeo; Morte cardiovascolare o peggioramento dell'insufficienza cardiaca; Re-infarto miocardico, ictus o rivascolarizzazione coronarica non programmata; Mortalità globale; Durata della degenza; Valori pressori arteriosi; Effetti collaterali; Caratteristiche anatomiche cardiache alla risonanza magnetica ed ecocardiografia; Differenza dei valori ematochimici di laboratorio (peptide natriuretico di tipo B, funzionalità renale, eritropoietina, ematocrito) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 months; 3 months; 3 months; 3 months; Discharge; Discharge and 3 months; 3 months; Baseline and 3 months; Baseline and 3 months |
3 mesi; 3 mesi; 3 mesi; 3 mesi; Dimissione; Dimissione e 3 mesi; 3 mesi; ingresso e 3 mesi; Ingresso e 3 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 | 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) | 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 | No |
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 |
terapia standard |
standard therapy |
|
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 | 12 |
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 | Information not present in EudraCT |
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 | 2 |
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 | 2 |
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 |