NCT03872401

Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,301 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.

Conditions

• Coronary Heart Disease (CHD)

Interventions

Type	Name	Description
DRUG	Evolocumab	Administered subcutaneously using an autoinjector pen.
DRUG	Placebo	Administered subcutaneously using an autoinjector pen.

Timeline

• Start date: 2019-06-11
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2019-03-13
• Last updated: 2025-11-10

Locations

852 sites across 33 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study