BENITIONSClinical Trial Intelligence

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

Phase 3 Completed NCT03872401

ConditionCoronary Heart Disease
PhasePhase 3
SponsorAmgen
StatusCompleted
Enrollment12,301 participants
InterventionsEvolocumab
Start dateJun 11, 2019
Completion dateJul 25, 2025
Results postedJun 25, 2026

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.

Number of Participants Who Experienced Coronary Heart Disease (CHD) Death, Myocardial Infarction (MI), or Ischemic Stroke, Whichever Occurred First

From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months · Participants

Placebo Q2W443 Participants
Evolocumab 140 mg Q2W336 Participants
p-value< 0.001
Hazard Ratio (HR)0.75 (95% CI 0.65–0.86)

Number of Participants Who Experienced CHD Death, MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization, Whichever Occurred First

From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months · Participants

Placebo Q2W907 Participants
Evolocumab 140 mg Q2W747 Participants
p-value< 0.001
Hazard Ratio (HR)0.81 (95% CI 0.73–0.89)

Open in BENITIONS View on ClinicalTrials.gov

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