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

Phase 3

Completed

• Conditions: Coronary Heart Disease (CHD)
• Interventions: Drug: Placebo; Drug: Evolocumab

• Registration Number: NCT03872401
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-11
• Study First Posted: 2019-03-13
• Study Start: 2019-06-11
• Primary Completion: 2025-07-25
• Study Completion: 2025-07-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12301

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo subcutaneous injection once every 2 weeks (Q2W).
Evolocumab 140 mg Q2W	Evolocumab	Participants will receive 140 mg evolocumab by subcutaneous injection Q2W.

Primary Outcome Measures

Name	Time	Method
Time to Coronary Heart Disease Death, Myocardial Infarction, or Ischemic Stroke	From randomization; for approximately a median of 4.5 years	Time to coronary heart disease (CHD) death, myocardial infarction (MI), or ischemic stroke, whichever occurs first.
Time to Coronary Heart Disease Death, Myocardial Infarction, Ischemic Stroke, or Any Ischemia-driven Arterial Sroke	From randomization; for approximately a median of 4.5 years	Time to CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Time to Cardiovascular Death	From randomization; for approximately a median of 4.5 years
Time to Ischemic Stroke	From randomization; for approximately a median of 4.5 years
Time to CHD Death, MI, or Any Ischemia-driven Arterial Revascularization	From randomization; for approximately a median of 4.5 years
Time to Cardiovascular Death, MI, or Ischemic Stroke	From randomization; for approximately a median of 4.5 years
Time to CHD Death or MI	From randomization; for approximately a median of 4.5 years
Time to All Cause of Death	From randomization; for approximately a median of 4.5 years
Time to MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization	From randomization; for approximately a median of 4.5 years
Time to Myocardial Infarction	From randomization; for approximately a median of 4.5 years
Time to Any Ischemia-driven Arterial Revascularization	From randomization; for approximately a median of 4.5 years
Time to CHD Death	From randomization; for approximately a median of 4.5 years

Trial Locations

Locations (842)

North Alabama Research Center LLC; 🇺🇸 Athens, Alabama, United States

Cardiovascular Associates; 🇺🇸 Birmingham, Alabama, United States

Heart Center Research LLC; 🇺🇸 Huntsville, Alabama, United States

Mobile Heart Specialists PC; 🇺🇸 Mobile, Alabama, United States

Arkansas Cardiology; 🇺🇸 Little Rock, Arkansas, United States

Central Arkansas Veterans Healthcare System; 🇺🇸 Little Rock, Arkansas, United States

Cardiovascular Research Foundation of Southern California; 🇺🇸 Beverly Hills, California, United States

Westside Medical Associates of Los Angeles; 🇺🇸 Beverly Hills, California, United States

West Coast Research LLC; 🇺🇸 Dublin, California, United States

Desert Oasis Healthcare Medical Group; 🇺🇸 Palm Springs, California, United States

Scroll for more (832 remaining)