Resumen

The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).

Age: 18 Years to 85 Years old

Género: Todos

Fecha de inicio: 12/14/2022

Fecha de finalización principal (estimada): 03/31/2028

Fecha estimada de finalización del estudio: 03/31/2028

Acepta voluntarios sanos: No

Propósito y descripción del ensayo

Criterios de elegibilidad

Age: 18 Years to 85 Years old

Género: Todos

Acepta voluntarios sanos: No

Criterios de inclusión:

* Edad de 18 a ≤ 85 años

* Lp(a) ≥ 200 nmol/L during screening

* History of ASCVD as evidenced by history of either:

* Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or

* Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.

Criterios de exclusión:

* Severe renal dysfunction

* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening

* History of hemorrhagic stroke

* History of major bleeding disorder

* Planned cardiac surgery or arterial revascularization

* Severe heart failure

* Current, recent, or planned lipoprotein apheresis

* Previously received ribonucleic acid therapy specifically targeting Lp(a)