Summary

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

Gender: All

Start Date: 12/14/2022

Primary Completion Date (Estimated): 03/31/2028

Study Completion Date (Estimated): 03/31/2028

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years to 85 Years old

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* Age 18 to ≤ 85 years

* 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.

Exclusion criteria:

* 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)