Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Фаза 3
Завершено
NCT03872401
| Заболевание | Coronary Heart Disease |
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| Фаза | Фаза 3 |
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| Спонсор | Amgen |
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| Статус | Завершено |
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| Участники | 12,301 участн. |
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| Вмешательство | Evolocumab |
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| Дата начала | 11.06.2019 |
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| Дата завершения | 25.07.2025 |
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| Публикация результатов | 25.06.2026 |
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Кратко
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) |
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