Resumen

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Edad: De 18 a 80 años

Género: Todos

Fecha de inicio: 12/12/2019

Fecha de finalización principal (estimada): 06/30/2026

Fecha estimada de finalización del estudio: 06/30/2026

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

Criterios de elegibilidad

Edad: De 18 a 80 años

Género: Todos

Acepta voluntarios sanos: No

Key Inclusion Criteria

* Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory

* Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit

* Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit

* Clinically significant symptomatic peripheral artery disease

Key Exclusion Criteria

* Hipertensión no controlada

* Heart failure New York Heart Association (NYHA) class IV

* History of malignancy of any organ system

* History of hemorrhagic stroke or other major bleeding

* Recuento de plaquetas ≤LLN

* Active liver disease or hepatic dysfunction

* Significant kidney disease

* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.