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 |
Heart Attack |
Attacco di cuore |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute 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 |
To evaluate the efficacy of CSL112 in reducing the risk of MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)] in subjects with ACS (Acute Coronary Syndrome),[diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI(Non-ST-segment elevation myocardial infarction)]. |
Valutare l’efficacia di CSL112 nel ridurre il rischio di MACE [Major Adverse Cardiovascular Event, eventi avversi cardiovascolari maggiori][(morte CV (cardiovascolare), MI (Myocardial Infarction, infarto miocardico) o ictus)] in soggetti affetti da ACS (Acute Coronary Syndrome, sindrome coronarica acuta) [con diagnosi di STEMI (ST-Segment Elevation Myocardial Infarction, infarto miocardico con sopraslivellamento del segmento ST) o NSTEMI (Non-ST-Segment Elevation Myocardial Infarction, infarto miocardico senza sopraslivellamento del segmento ST)]. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for coronary, cerebral, or peripheral ischemia. 2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) in ACS (diagnosed with STEMI or NSTEMI) through 180 and 365 days |
1. Valutare l’efficacia di CSL112 nel ridurre il numero totale di ricoveri ospedalieri per ischemia coronarica, cerebrale o periferica. 2. Valutare l’efficacia di CSL112 nel ridurre il rischio di MACE (morte CV, MI o ictus) in pazienti affetti da ACS (con diagnosi di STEMI o NSTEMI) fino al giorno 180 e al giorno 365. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female least 18 years of age 2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI 3. No suspicion of acute kidney injury 4. Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors:age = 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease |
1. Soggetti di sesso maschile o femminile di età pari ad almeno 18 anni 2. Evidenza di necrosi miocardica, in linea con il tipo di MI (spontaneo) 3. Nessun sospetto di lesione renale acuta 4. Evidenza di malattia coronarica multivasale e almeno 1 dei seguenti fattori di rischio stabiliti: età = 65 anni, precedenti di MI, diabete mellito o arteriopatia periferica |
|
E.4 | Principal exclusion criteria |
1. Ongoing hemodynamic instability 2. Evidence of hepatobiliary disease 3. Evidence of severe chronic kidney disease 4. Plan to undergo scheduled coronary artery bypass graft surgery 5. Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin |
1. Instabilità emodinamica in corso 2. Evidenza di malattia epatobiliare 3. Evidenza di nefropatia cronica grave 4. Previsione di intervento chirurgico di bypass aortocoronarico 5. Anamnesi nota di allergie, ipersensibilità o carenze connesse a soia, arachidi o albumina
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) |
Tempo alla prima insorgenza di qualsiasi componente di MACE composito (morte CV, MI o ictus)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Through 90 days |
Fino al giorno 90 |
|
E.5.2 | Secondary end point(s) |
1) Total number of hospitalizations for coronary, cerebral, or peripheral ischemia 2) and 3) Time to first occurrence of CV death, MI, or stroke 4) Time to occurrence of CV death 5) Time to first occurrence of MI 6) Time to first occurrence of stroke 7) Time to occurrence of all-cause death 8) Number and percent of subjects with adverse events 9) Number and percent of subjects with treatment-related adverse events 10) Number and percent of subjects with serious adverse events 11) Number and percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low) |
1) Numero totale di ricoveri ospedalieri per ischemia coronarica, cerebrale o periferica 2) e 3) Tempo alla prima insorgenza di morte CV, MI o ictus 4) Tempo all’insorgenza di morte CV 5) Tempo alla prima insorgenza di MI 6) Tempo alla prima insorgenza di ictus 7) Tempo all’insorgenza di morte per qualsiasi causa 8) Numero e percentuale di soggetti con eventi avversi 9) Numero e percentuale di soggetti con eventi avversi correlati al trattamento 10) Numero e percentuale di soggetti con eventi avversi gravi 11) Numero e percentuale di soggetti con una variazione nelle valutazioni cliniche di laboratorio dal basale rispetto al peggior valore post-trattamento secondo i criteri di intervallo normali (normale, alto o basso)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1), 4), 5), 6), 8): Through 90 days 2): Through 180 days 3), 7), 9), 10): Through 365 days 11): Baseline and 29 days |
1), 4), 5), 6), 8): Fino al giorno 90 2): Fino al giorno 180 3), 7), 9), 10): Fino al giorno 365 11): Basale e 29 giorni
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 377 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
Canada |
Chile |
Colombia |
Hong Kong |
Israel |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Russian Federation |
Serbia |
Singapore |
South Africa |
Taiwan |
Thailand |
Turkey |
Ukraine |
United States |
Switzerland |
European Union |
Argentina |
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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 | 50 |
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 | 50 |
E.8.9.2 | In all countries concerned by the trial days | 0 |