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A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501608-85-00
Acronym
20180244
Enrollment
3511
Registered
2023-05-03
Start date
2023-05-09
Completion date
Unknown
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease (atherosclerotic cardiovascular disease (ASCVD) and elevated lipoprotein (a))

Brief summary

Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

Detailed description

Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first, Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first, Percent change from baseline to week 48 in Lp(a), • time to myocardial infarction • time to CHD death or myocardial infarction, whichever occurs first • time to urgent coronary revascularization • time to coronary revascularization • time to CHD death • time to cardiovascular death • time to death by any cause • time to ischemic stroke, Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs), serious adverse events, and adverse events leading to discontinuation of investigational product, serum concentration of olpasiran at selected timepoints

Interventions

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first

Secondary

MeasureTime frame
Time to cardiovascular death, myocardial infarction, or ischemic stroke, whichever occurs first, Time to cardiovascular death, myocardial infarction, urgent coronary revascularization, or ischemic stroke, whichever occurs first, Percent change from baseline to week 48 in Lp(a), • time to myocardial infarction • time to CHD death or myocardial infarction, whichever occurs first • time to urgent coronary revascularization • time to coronary revascularization • time to CHD death • time to cardiovascular death • time to death by any cause • time to ischemic stroke, Treatment-emergent adverse events (including clinically significant changes in laboratory values and vital signs), serious adverse events, and adverse events leading to discontinuation of investigational product, serum concentration of olpasiran at selected timepoints

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026