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 |
Acute coronary syndrome |
Síndrome coronario agudo |
|
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 | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
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 compare the effect of SAR236553 (REGN727) with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia |
Comparar el efecto de SAR236553 con el de un placebo sobre la aparición de acontecimientos cardiovasculares (criterio de valoración compuesto de muerte por cardiopatía coronaria (CC), infarto de miocardio no mortal (IM), accidente cerebrovascular isquémico mortal y no mortal, angina inestable con hospitalización) en pacientes que hayan experimentado un síndrome coronario agudo (SCA) entre 4 y 16 semanas antes de la aleatorización y reciban tratamiento intensivo con estatinas (definido como la administración de 40 u 80 mg de atorvastatina, o bien de 20 o 40 mg de rosuvastatina) o con la dosis máxima tolerada de dichas estatinas, o bien con otros tratamientos modificadores de los lípidos (lipid-modifying theraphy, LMT) no estatínicos |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of SAR236553 (REGN727) on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality).
To evaluate the safety and tolerability of SAR236553 (REGN727).
To evaluate the effect of SAR236553 (REGN727) on lipid parameters. |
Comparar la eficacia de SAR236553 en comparación con placebo sobre los criterios de valoración secundarios (cualquier acontecimiento de CC, acontecimiento importante de CC, cualquier acontecimiento CV, combinación de mortalidad por cualquier causa/IM no mortal/accidente cerebrovascular isquémico no mortal y mortalidad por cualquier causa).
Se creará un comité de acontecimientos clínicos (CEC) para decidir, con enmascaramiento, los acontecimientos correspondientes a los criterios de valoración cardiovasculares principal y secundario, así como todas las causas de muerte.
? Evaluar la seguridad y la tolerabilidad de SAR236553 a lo largo del estudio.
? Evaluar el desarrollo de anticuerpos antiSAR236553.
? Evaluar el efecto de SAR236553 sobre el colesterol de lipoproteínas de baja densidad (LDL-C), la apolipoproteína B (ApoB) y el colesterol de lipoproteínas de no alta densidad (no HDL-C). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
o Recently hospitalized for ACS. |
Recientemente hospitalizados por síndrome coronario agudo. |
|
E.4 | Principal exclusion criteria |
o Age < 40 years.
o ACS event occurring more than 16 weeks prior to randomization visit.
o LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia. |
- Edad inferior a 40 años
- Pacientes que hayan experimentado un acontecimiento de SCA más de 16 semanas (+ 3 días) antes de la visita de aleatorización (V3).
- LDL-C < 70 mg/dl (< 1,81 mmol/l con evidencia sobre el manejo médico y dietético de la dislipidemia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time from randomization to first occurrence of one of the following Clinical Events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization |
Periodo transcurrido desde la aleatorización hasta la primera aparición de uno de los siguientes acontecimientos clínicos, según el CEC:
- Muerte por CC.
- IM no mortal.
- Accidente cerebrovascular isquémico mortal y no mortal.
- Hospitalización por angina inestable. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to Month 64 |
Hasta el mes 64 |
|
E.5.2 | Secondary end point(s) |
- Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality
- Change from baseline in blood lipids and lipoprotein levels
- Number of patients with adverse events |
- Periodo transcurrido hasta la primera aparición de cualquier acontecimiento de CC (acontecimiento importante de CC, angina inestable con hospitalización y hospitalización por intervención de revascularización coronaria imprevista).
- Periodo transcurrido desde la aleatorización hasta la primera aparición de cualquier acontecimiento de CC (muerte por CC, IM no mortal).
- Periodo transcurrido desde la aleatorización hasta la primera aparición de cualquier acontecimiento CV definido del modo siguiente: cualquier acontecimiento de CC no mortal, cualquier muerte por causa CV y accidente cerebrovascular isquémico no mortal.
- Periodo transcurrido desde la aleatorización hasta la primera aparición de mortalidad por cualquier causa, IM no mortal o accidente cerebrovascular isquémico no mortal.
- Periodo transcurrido desde la aleatorización hasta la muerte (mortalidad por cualquier causa).
- Cambio porcentual en el LDL-C calculado, en la ApoB y en el no HDL-C.
- Número de pacientes con acontecimentos adversos |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to Month 64 |
Hasta el mes 64 |
|
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 | Yes |
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 | 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 | 30 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 410 |
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 |
Austria |
Belarus |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Colombia |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Hong Kong |
Hungary |
India |
Israel |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Norway |
Peru |
Philippines |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovakia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Thailand |
Turkey |
Ukraine |
United Kingdom |
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
|
LVLS |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |