Summary

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)

Age: 18 Years to 80 Years old

Gender: All

Start Date: 12/12/2019

Primary Completion Date (Estimated): 06/30/2026

Study Completion Date (Estimated): 06/30/2026

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 18 Years to 80 Years old

Gender: All

Accepts Healthy Volunteers: 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

* Uncontrolled hypertension

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

* History of malignancy of any organ system

* History of hemorrhagic stroke or other major bleeding

* Platelet count ≤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.