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

Conditions

• Coronary Heart Disease (CHD)

Eligibility Criteria

Sex

ALL

Age

50 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — DRUG
  Administered subcutaneously using an autoinjector pen.
• Placebo — DRUG
  Administered subcutaneously using an autoinjector pen.

Study Details

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.

Key Dates

Start date

Jun 11, 2019

Status verified

Nov 2025

Primary completion

Jul 25, 2025

Completion

Jul 25, 2025

Study Design

Enrollment

12,301 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W).
• Experimental: Evolocumab 140 mg Q2W
  Participants will receive 140 mg evolocumab by subcutaneous injection Q2W.

Primary Outcome Measure

Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke [ Time Frame: From randomization; for approximately a median of 4.5 years ]

Locations (145)

Related coverage on Hipa.ai

• Evolocumab Phase 3 Trial for High CV Risk Patients Completes Primary Data…
  Evolocumab · Jul 25, 2025 · ClinicalTrials.gov

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