E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
All (male and female) patients, aged over 18, presenting with a large STEMI not older than 4 hours (defined as angina pectoris or equivalent symptoms of more than 30 minutes duration within the last 4 hours and a sum of ST-elevation > 4mm), with a TIMI-flow 0 or 1 in the identified culprit artery, for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) are eligible for the study. |
Pazienti di entrambi i sessi, >=18 anni, con uno STEMI esteso (definito come angina pectoris o sintomi equivalenti da più di 20 minuti, nelle prime 4 ore dall’inizio dei sintomi e un sopraslivellamento del tratto ST in almeno 3 derivazioni in sede anteriore e/o una deviazione in almeno 4 derivazioni in sede inferiore, associato a un flusso TIMI 0 o 1 nella coronaria Colpevole dello STEMI), con indicazione alla angioplastica primaria (PCI). |
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E.1.1.1 | Medical condition in easily understood language |
Patients admitted within 4 hours of symptom onset of acute myocardial infarction with ST segment elevation, candidates for primary angioplasty. |
Pazienti ricoverati entro 4 ore dall'inizio dei sintomi di infarto miocardico acuto, con slivellamento del tratto ST, candidati per angioplastica primaria. |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064345 |
E.1.2 | Term | ST segment elevation myocardial infarction |
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 primary objective of the present study is improvement of myocardial reperfusion, measured with ST-segment resolution >=70% 1 hour after PCI. |
Obiettivo primario di questo studio è il miglioramento della riperfusione miocardica, valutata con la risoluzione del tratto ST>=70% 1 ora dopo PCI. |
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E.2.2 | Secondary objectives of the trial |
High sesnsitive troponin T (hsTnT) at day 4 after PCI. All-cause mortality, HF or shock within 6 months of randomization; re-hospitalization for CV reasons within 6 months of randomization. |
Troponina-T ad alta sensibilità (hsTnT) in 4a giornata dopo PCI, mortalità totale, insufficienza cardiaca sintomatica o shock cardiogeno o riospedalizzazione per ragioni cardiovascolari nei 6 mesi seguenti la randomizzazione. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All (male and female) patients, aged over 18, presenting with a large STEMI within 4 hours of onset (defined as angina pectoris or equivalent symptoms of more than 20 minutes duration within the last 4 hours and ST elevation in ≥ 3 leads in anterior MI and/or a deviation in ≥ 4 leads in inferior MI, with a TIMI-flow 0 or 1 in the culprit artery, committed to treatment with PCI) are eligible for the study. Patients will only be included if they are able to understand the nature, scope, and possible consequences of study participation, and written informed consent will be sought. |
Pazienti di entrambi i sessi, >=18 anni, con uno STEMI esteso (definito come angina pectoris o sintomi equivalenti da più di 20 minuti, nelle prime 4 ore dall’inizio dei sintomi e un sopraslivellamento del tratto ST in almeno 3 derivazioni in sede anteriore e/o una deviazione in almeno 4 derivazioni in sede inferiore, associato a un flusso TIMI 0 o 1 nella coronaria colpevole dello STEMI), con indicazione alla angioplastica primaria (PCI).I pazienti saranno arruolati solo se in grado di comprendere la natura, lo scopo e le possibili conseguenze legate alla loro partecipazione allo studio; verrà richiesta la firma di consenso informato. |
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E.4 | Principal exclusion criteria |
Left bundle branch block; TIMI-flow >1 in the identified culprit artery; current (≤ 10 days) treatment with CsA or contraindication regarding treatment with CsA; coronary anatomy not suitable for PCI; thrombolytic therapy within 24 hrs. before randomization; previous myocardial infarction; previous CABG; severe renal or hepatic insufficiency; malignant tumor, not curatively treated; women with childbearing potential, esp. pregnant or nursing women; participation in another clinical or device trial within the previous 30 days. |
blocco di branca sinistra; flusso TIMI>1 nella coronaria colpevole; terapia con CsA entro i 10 giorni precedenti la randomizzazione o controindicazioni alla CsA; anatomia coronarica inadatta a PCI; terapia trombolitica nelle 24 ore precendenti la randomizzazione; IMA pregresso; CABG pregresso; insufficienza renale o epatica grave; tumore maligno, non curabile; donna in età fertile, specie se gravida o in allattamento; partecipazione ad un altro trial clinico negli ultimi 30 giorni. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of myocardial reperfusion, measured with ST-segment resolution >=70% |
miglioramento della riperfusione miocardica, valutata con la risoluzione del tratto ST>=70% |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 hour after PCI. |
1 ora dopo PCI. |
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E.5.2 | Secondary end point(s) |
Troponin (hsTnT) at day 4 after PCI, all-cause mortality, HF or shock within 6 months of randomization; re-hospitalization for CV reasons. |
Troponina (hsTnT) in 4a giornata dopo PCI, mortalità totale, insufficienza cardiaca sintomatica o shock cardiogeno o riospedalizzazione per ragioni cardiovascolari nei 6 mesi seguenti la randomizzazione. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Troponin T: 4 hours; Echocardiography: pre-discharge and 6 months |
Troponina T: 4 ore; Ecocardiografia: pre-dimissione e 6 mesi |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
non trattati con ciclosporina A |
untreated with ciclosporin A |
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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
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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 | 24 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |