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A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503673-38-00
Acronym
20170625
Enrollment
6020
Registered
2024-04-08
Start date
2019-05-24
Completion date
2025-07-16
Last updated
2025-11-14

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

Conditions

Adults at high risk of cardiovascular events without prior MI or stroke.

Brief summary

Time to CHD death, MI, or ischemic stroke, whichever occurs first, Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first

Detailed description

Time to MI, ischemic stroke, or any ischemia-driven arterial revascularization, Time to CHD death, MI, or any ischemia-driven arterial revascularization, Time to cardiovascular death, MI, or ischemic stroke, Time to CHD death or MI, Time to MI, Time to any ischemia-driven arterial revascularization, Time to CHD death, Time to cardiovasular death, Time to all cause of death, Time to ischemic stroke

Interventions

DRUGPlacebo for AMG 145
DRUGEVOLOCUMAB

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to CHD death, MI, or ischemic stroke, whichever occurs first, Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first

Secondary

MeasureTime frame
Time to MI, ischemic stroke, or any ischemia-driven arterial revascularization, Time to CHD death, MI, or any ischemia-driven arterial revascularization, Time to cardiovascular death, MI, or ischemic stroke, Time to CHD death or MI, Time to MI, Time to any ischemia-driven arterial revascularization, Time to CHD death, Time to cardiovasular death, Time to all cause of death, Time to ischemic stroke

Countries

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

Outcome results

None listed

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