Resumen

Se trata de un ensayo clínico aleatorizado abierto a nivel de paciente 1:1, multicéntrico e internacional, cuyo objetivo es evaluar el impacto en la práctica real de inclisiran más atención habitual (AH) versus AH sola sobre la reducción de LDL-C, los resultados informados por los pacientes y la utilización de recursos sanitarios en una población hospitalaria admitida durante el evento agudo, estabilizada y antes del alta, tras un evento cardiovascular agudo.

Descripción detallada

El objetivo primario es evaluar el impacto de inclisiran más atención habitual sobre la reducción de LDL-C en comparación con la atención habitual sola tras un infarto agudo de miocardio, accidente cerebrovascular isquémico confirmado o revascularización coronaria urgente. El objetivo secundario es comparar la reducción de LDL-C de ambos brazos en la población objetivo. La finalización del estudio para un participante individual se define como el momento en que el participante completa la última visita (día 330) y las evaluaciones asociadas a dicha visita.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.
Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:
Was not in cardiogenic shock.
Did not required invasive hemodynamic, inotropic or vasopressor support.
Participants are required to be eligible for receiving inclisiran in accordance to approved local label.
Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization.

Criterios de exclusión

Currently on PCSK9i therapy (within last 3 months)
Current participation in another clinical study with another study drug
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

Intervenciones

drug

Usual care

Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines

drug

KJX839

Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270

Ubicaciones

Novartis Investigative Site

Corrientes, Argentina

RECRUITING

Patrocinadores

PrincipalNovartis Pharmaceuticals

Contactos

Novartis Pharmaceuticals

CONTACT

novartis.email@novartis.com +41613241111

Novartis Pharmaceuticals

CONTACT

Optimización lipídica en América Latina tras evento agudo en pacientes con enfermedad cardiovascular aterosclerótica y LDL-C elevado

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Usual care

KJX839

Ubicaciones

Novartis Investigative Site

Patrocinadores

Contactos

Novartis Pharmaceuticals

Novartis Pharmaceuticals