Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Phase 3
Completed
NCT03872401
| Condition | Coronary Heart Disease |
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| Phase | Phase 3 |
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| Sponsor | Amgen |
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| Status | Completed |
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| Enrollment | 12,301 participants |
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| Interventions | Evolocumab |
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| Start date | Jun 11, 2019 |
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| Completion date | Jul 25, 2025 |
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| Results posted | Jun 25, 2026 |
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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 Q2W | 443 Participants |
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| Evolocumab 140 mg Q2W | 336 Participants |
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| 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 Q2W | 907 Participants |
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| Evolocumab 140 mg Q2W | 747 Participants |
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| 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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