E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute ST-segment elevation myocardial infarction (STEMI) with large coronary thrombus burden (LCTB). |
infarto acuto del miocardio con elevazione del tratto ST (STEMI) con elevato carico trombotico |
|
E.1.1.1 | Medical condition in easily understood language |
acute heart attack caused by the occlusion of a coronary artery by a large amount of thrombus. |
infarto acuto del cuore causato dall'occlusione di una arteria coronaria da parte di una grande quantità di trombo. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 reduction of thrombus burden and thrombus volume, measured as the difference of Thrombotic Score between baseline and control at OCT. The control angiography and OCT will be performed between day 5 th and 7 th . The primary coagulation-related of the study is the factor XIa activity at baseline and after 4-7 days of treatments |
la riduzione del carico trombotico e del volume trombotico intracoronarico, misurato come differenza del Thrombotic Score all’OCT tra basale e controllo. L'angiografia e l’OCT di controllo saranno eseguiti tra il 5 ° e il 7 ° giorno. L'attività del fattore XIa valutata al basale e dopo 4-7 giorni di trattamento |
|
E.2.2 | Secondary objectives of the trial |
Coagulation cascade factors activity at presentation and after 4-7 days Factor Xa and IIa (common pathway) Factor XIa and VIIIa (intrinsic pathway) Factor VIIa (extrinsic pathway) Angiographic outcomes before stenting implantation: White vs. red thrombus presence Angiographic outcomes after stenting implantation: Final TIMI flow; Final TIMI frame count; Final myocardial blush grade; Clinical outcomes at 30 days: - The percentage of patients with MACE (composite of all cause death, myocardial infarction, stroke or new target vessel revascularization) - The percentage of patients with major bleeding - The percentage of patients with any bleeding Safety outcome at 30 days: the rate of major bleedings at 30-day |
L'attività dei fattori di cascata della coagulazione alla presentazione e dopo 4-7 giorni -Fattore Xa e IIa (via comune) -Fattore XIa e VIIIa (via intrinseca) -Fattore VIIa (via estrinseca) Esiti angiografici prima dell'impianto di stent: presenza di trombo bianco o trombo rosso Esiti angiografici dopo l'impianto di stent: -flusso TIMI finale, -TIMI Frame Count (TFC) -Myocardial Blush Grade (MBG). Esiti clinici a 30 giorni: - La percentuale di pazienti con MACE (morte per tutte le cause, infarto del miocardio, ictus o rivascolarizzazione di nuovo vaso target) - La percentuale di pazienti con sanguinamento maggiore (BARC uguale o maggiore a 3) - La percentuale di pazienti con sanguinamento di qualsiasi grado (secondo classificazione BARC). Risultato di sicurezza a 30 giorni: tasso di sanguinamenti maggiori a 30 giorni (BARC uguale o maggiore a 3) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis of acute STEMI with a large thrombotic burden |
STEMI acuto con elevato carico trombotico. |
|
E.4 | Principal exclusion criteria |
-Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding -Cardiogenic shock at presentation or life-threatening electrical instability. |
- qualsiasi condizione che, secondo parere dello sperimentatore, possa controindicare il trattamento anticoagulante o possa costituire un rischio di sanguinamento inaccettabile. - Shock cardiogeno al momento della presentazione o instabilità emodinamica secondaria ad aritmie maligne. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The reduction of thrombus burden and thrombus volume, measured as the difference of Thrombotic Score between baseline and control at OCT. The control angiography and OCT will be performed between day 5 th and 7 th . The primary coagulation-related of the study is the factor XIa activity at baseline and after 4-7 days of treatments |
la riduzione del carico trombotico e del volume trombotico intracoronarico, misurato come differenza del Thrombotic Score all’OCT tra basale e controllo. L'angiografia e l’OCT di controllo saranno eseguiti tra il 5 ° e il 7 ° giorno. L'attività del fattore XIa valutata al basale e dopo 4-7 giorni di trattamento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Coagulation cascade factors activity at presentation and after 4-7 days Factor Xa and IIa (common pathway) Factor XIa and VIIIa (intrinsic pathway) Factor VIIa (extrinsic pathway) Angiographic outcomes before stenting implantation: White vs. red thrombus presence Angiographic outcomes after stenting implantation: Final TIMI flow; Final TIMI frame count; Final myocardial blush grade; Clinical outcomes at 30 days: - The percentage of patients with MACE (composite of all cause death, myocardial infarction, stroke or new target vessel revascularization) - The percentage of patients with major bleeding - The percentage of patients with any bleeding Safety outcome at 30 days: the rate of major bleedings at 30-day |
L'attività dei fattori di cascata della coagulazione alla presentazione e dopo 4-7 giorni -Fattore Xa e IIa (via comune) -Fattore XIa e VIIIa (via intrinseca) -Fattore VIIa (via estrinseca) Esiti angiografici prima dell'impianto di stent: presenza di trombo bianco o trombo rosso Esiti angiografici dopo l'impianto di stent: -flusso TIMI finale, -TIMI Frame Count (TFC) -Myocardial Blush Grade (MBG). Esiti clinici a 30 giorni: - La percentuale di pazienti con MACE (morte per tutte le cause, infarto del miocardio, ictus o rivascolarizzazione di nuovo vaso target) - La percentuale di pazienti con sanguinamento maggiore (BARC uguale o maggiore a 3) - La percentuale di pazienti con sanguinamento di qualsiasi grado (secondo classificazione BARC). Risultato di sicurezza a 30 giorni: tasso di sanguinamenti maggiori a 30 giorni (BARC uguale o maggiore a 3) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
7 and 30 days |
7 e 30 giorni |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Information not present in EudraCT |
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 | 8 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |