E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with left ventricular systolic disfunction after revascularization for acute myocardial infarction |
Pazienti con ridotta FE dopo rivascolarizzazione efficace durante infarto acuto anteriore |
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E.1.1.1 | Medical condition in easily understood language |
Acute myocardial infarction |
Infarto miocardico acuto |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
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 |
To demonstrate that G-CSF therapy in addition to state of the art treatment (pharmacological and non pharmacological) is safe and significantly improves clinical outcome in patients with reduced left ventricular EF (≤ 45%) after successful reperfusion for anterior acute MI |
Dimostrare che il G-CSF, somministrato in aggiunta al trattamento standard (farmacologico e non) dell’infarto miocardio acuto è sicuro e migliora significativamente l’outcome clinico in pazienti con ridotta FE (≤ 45%) dopo rivascolarizzazione efficace durante infarto acuto anteriore |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Randomized study on STEM cells by G-CSF in patient with left ventricular systolic disfunction after large anterior acute myocardial infarction: STEM-AMI2 Trial
10/12/2012 - V. 1.0
To evaluate if the treatment with G-CSF can improve left ventricular systolic function to reduce the necrosis area extention and improve left ventricular remodeling in patients with st elevation anterior acute myocardial infarction. |
Studio randomizzato di mobilizzazione di progenitori midollari con G-CSF in pazienti con disfunzione ventricolare successiva ad infarto miocardico anteriore esteso: STEM-AMI2 TRIAL.
10/12/2012 – V. 1.0
Valutare se il trattamento con G-CSF è in grado di migliorare la funzione sistolica del ventricolo sinistro, ridurre l’estensione dell’area infartuale e migliorare il rimodellamento del ventricolo sinistro nei pazienti con Infarto miocardico acuto, ST sopra a sede anteriore
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E.3 | Principal inclusion criteria |
Patients affected by acute anterior STEMI undergoing primary PCI or PCI-rescue with persistent occlusion of coronary artery,
Time symptom-to-balloon (≥3 h and ≤12h or ≤24 h if symptoms persist),
TIMI flow post PCI ≥2,
Evidence of left ventricular dysfunction (EF biplane 45%) ≤24 h after revascularization,
Men and women aged ≥18 years and ≤75 years,
Informed consent must be signed before proceeding with any study procedure.
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Pazienti affetti da STEMI anteriore sottoposti a PCI primaria o PCI rescue con evidenza di occlusione coronarica,
Time symptom-to-balloon ≥ 3 ore e ≤ 12 ore o ≤ 24 ore in caso di persistenza dei sintomi,
Evidenza di disfunzione Vsx (FE biplana ≤ 45%) misurata entro 24 ore dalla rivascolarizzazione,
TIMI flow ≥ 2 post PCI,
Uomini e donne di età ≥ 18 anni e ≤ 75 anni,
Consenso informato firmato. |
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E.4 | Principal exclusion criteria |
Previous anterior MI,
Recent MI (within 1 month),
Known previous LV dysfunction (EF <45%),
Patients with angiographic evidence of coronary anatomy not suitable for PCI, or needing coronary artery bypass grafting (CABG),
Valve disease requiring surgical correction,
History of previous cardiac surgery or PCI on LAD within 6 months,
Previous or current documented history of leukemia, myeloproliferative or myelodisplastic disorder,
Previous or current documented history of malignant disease,
Haemoglobin <10 mg/dl,
White blood cells (WBC) >25.000 mm3,
Platelet <50.000 mm3,
Sepsis,
Known HIV infection,
Immune system diseases,
Interstitial lung disease
Serious concomitant medical conditions (other than ischemic heart disease),
Pregnancy and breast feeding,
Documented alcohol and drug abuse,
Anticipated poor compliance.
Current participation in a clinical trial with other investigational products
Other cell therapy.
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Pregresso infarto miocardico anteriore,
Infarto miocardico recente (nel mese precedente)
Nota pregressa disfunzione Vsx (FE < 45%),
Pazienti con evidenza angiografica di stenosi coronariche non trattabili mediante PCI ma candidati a by-pass aorto-coronarico (CABG),
Evidenza di valvulopatia con indicazione chirurgica,
Pregresso intervento cardiochirurgico o PCI sulla discendente anteriore nei 6 mesi precedenti,
Pregressa o attuale documentazione di leucemia, malattie mieloproliferative o disordini mielodisplastici,
Pregressa o attuale documentazione di malattie neoplastiche,
Hb < 10 g%,
Conta dei globuli bianchi > 25.000 mm3,
Conta piastrinica < 50.000/mm3,
Sepsi,
Nota malattia da HIV,
Pregressa o attuale documentazione di patologie autoimmuni,
Interstiziopatia polmonare
Documentazione di concomitanti gravi patologie (non cardiache) non adeguatamente controllate,
Gravidanza o allattamento,
Documentato abuso di alcool e/o droghe,
Scarsa compliance.
Partecipazione a studi clinici con prodotti sperimentali
Terapia con cellule staminali
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E.5 End points |
E.5.1 | Primary end point(s) |
All cause death or,
recurrence of MI or,
hospitalization due to heart failure.
|
Mortalità totale o
recidiva di IMA o
ospedalizzazione per scompenso cardiaco
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 months from enrolment |
24 mesi dall'arruolamento |
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E.5.2 | Secondary end point(s) |
Efficacy endpoints
- All cause death,
- recurrence of MI,
- hospitalization due to heart failure,
- cardiovascular death,
- coronary revascularization,
- fatal and non fatal stroke,
- hospitalization due to any cause,
- cardiovascular hospitalization,
- resuscitation and/or appropriate AICD therapy.
Safety endpoints
- Incidence and severity of bleeding complications,
- incidence of malignancy,
- incidence and intensity of SAEs and ADRs.
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Di efficacia:
- mortalità totale
- recidiva di IMA
- ospedalizzazione per scompenso cardiaco,
- morte cardiovascolare
- rivascolarizzazione coronarica
- stroke non fatale
- ospedalizzazioni per tutte le cause
- ospedalizzazioni cardiovascolari
- rianimazione cardiopolmonare/intervento appropriato di AICD
Di safety:
- incidenza e severità di complicanze emorragiche
- incidenza di neoplasie
- incidenza di reazioni avverse e eventi avversi seri
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 months from enrolment |
24 mesi dall'arruolamento |
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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) | 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 | No |
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 | 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 | 60 |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |