E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Coronary Syndrome |
Síndrome coronario agudo |
|
E.1.1.1 | Medical condition in easily understood language |
Heart Attack |
Ataque al corazón |
|
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 |
|
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)]. |
El objetivo principal de este estudio es evaluar la eficacia de CSL112 en la reducción del riesgo de AACI (muerte CV, IM o ictus) desde el momento de la aleatorización hasta los 90 días en pacientes con SCA (con diagnóstico de IMEST o IMSEST). |
|
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.Evaluar la eficacia de CSL112 en la reducción del número total de hospitalizaciones por isquemia coronaria, cerebral o periférica. 2.Evaluar la eficacia de CSL 112 en la reducción del riesgo de AACI(muerte CV, IM o ictus) hasta los 180 y 365 días en pacientes conSCA (con diagnóstico de IMEST o IMSEST). |
|
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. Hombres y mujeres de al menos 18 años de edad 2. Evidencia de necrosis de miocardio en un entorno clínicocoherente con IM de tipo I (espontáneo) 3. Sin sospecha de lesión renal aguda 4. Evidencia de arteriopatía coronaria multivascular que se definecomo que cumple 1 o más de los criterios siguientes: edad ≥ 65 años, antecedentes de IM, diabetes mellitus o arteriopatía periférica. |
|
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. Inestabilidad hemodinámica continua 2. Evidencia de enfermedad hepatobiliar 3. Evidencia de enfermedad renal crónica severa 4. Plan para someterse a cirugía de injerto de derivación de arteria coronaria programada 5. Historia conocida de alergias, hipersensibilidad o deficiencias a la soja, el maní o la albúmina |
|
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 ) |
Tiempo hasta el primer episodio de cualquier componente del AACI compuesto(muerte CV, infarto de miocardio o accidente cerebrovascular) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Through 90 days |
Hasta los 90 días |
|
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) Número total de hospitalizaciones por isquemia coronaria, cerebraloperiférica 2 y 3) Tiempo hasta el primer episodio de muerte CV, IM o ictus 4) Tiempo hasta el primer episodio de muerte CV 5) Tiempo hasta el primer episodio de IM 6) Tiempo hasta el primer episodio de ictus 7) Tiempo hasta el primer episodio de todas las causas de la muerte 8) Número y porcertaje de sujetos con eventosadversos 9) Número y porcentaje de sujetos con eventos adversos relacionados con el tratamiento 10) Número y porcentaje de sujetos con eventos adversos serios 11) Número y porcentaje de sujetos con cambio en las evaluaciones de laboratorio clínico desde el valor inicial hasta el peor valor postratamiento de acuerdo con los criterios de rango normal (normal, alto o bajo) |
|
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): Hasta 90 días 2): Hasta 180 días 3), 7), 9), 10): Hasta 365 días 11): Inicio y 29 días |
|
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 | 8 |
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 | No |
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 |
Argentina |
Australia |
Brazil |
Canada |
Chile |
Colombia |
European Union |
Hong Kong |
Israel |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Russian Federation |
Serbia |
Singapore |
South Africa |
Switzerland |
Taiwan |
Thailand |
Turkey |
Ukraine |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 50 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 50 |