CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,301 enrolled / 12,301 target
Drug / intervention
Evolocumab +1 moredrug
Likely dose
140 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03872401
NCT03872401Phase 3CompletedMonitor (145.2/mo)Completion was 11mo ago
CompareCT.gov

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

Amgen·interventional·Posted Mar 13, 2019·Updated Jun 25, 2026

In Brief

A Phase 3 clinical trial evaluating Evolocumab and Placebo for Coronary Heart Disease (CHD). Completed, enrolled 12,301 participants across 852 sites in 33 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Heart Disease (CHD)
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 13, 2019
Enrollment StartJun 11, 2019
Primary CompletionJul 25, 2025
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 7.3 years ago

Arms & Interventions

Placeboplacebo_comparator

Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W).

Drug: Placebo
Evolocumab 140 mg Q2Wexperimental

Participants will receive 140 mg evolocumab by subcutaneous injection Q2W.

Drug: Evolocumab

Interventions

Evolocumabdrug

Administered subcutaneously using an autoinjector pen.

Placebodrug

Administered subcutaneously using an autoinjector pen.