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Completed
NCT03872401
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Conditions: Coronary Heart Disease (CHD)
Sex: All
Ages: 50 Years – 79 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 12301
Sponsor: Amgen
Location: North Alabama Research Center LLC Athens Alabama
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.
Eligibility Criteria
Inclusion criteria:
* Age: Adult participants ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria.
* Lipid Criteria: Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non high-density lipoprotein cholesterol (non-HDL)-C ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L).
3.Diagnostic evidence of at least one of the following (A-D) at screening:
A.Significant coronary artery disease (CAD) meeting at least 1 of the following criteria:
* History of coronary revascularization with multi-vessel coronary disease as evidenced by any of the following:
1. percutaneous coronary intervention (PCI) of 2 or more vessels, including branch arteries,
2. PCI or coronary artery bypass grafting (CABG) with residual 50% stenosis in a separate, unrevascularized vessel, or
3. multi-vessel CABG 5 years or more prior to screening.
* Significant coronary disease without prior revascularization as evidenced by either a ≥70% stenosis of at least 1 coronary artery, ≥50% stenosis of 2 or more coronary arteries, or ≥50% stenosis of the left main coronary artery.
* known coronary artery calcium score ≥100 in participants without a coronary artery revascularization prior to randomization.
B. Significant atherosclerotic cerebrovascular disease meeting at least 1 of the following criteria:
* prior transient ischemic attack with ≥50% carotid stenosis.
* internal or external carotid artery stenosis of ≥70% or 2 or more ≥50% stenoses.
* prior internal or external carotid artery revascularization.
C. Significant peripheral arterial disease meeting at least 1 of the following criteria:
* ≥50% stenosis in a limb artery.
* history of abdominal aorta treatment (percutaneous and surgical) due to atherosclerotic disease.
* ankle brachial index (ABI) \
Source: ClinicalTrials.gov (NCT03872401). StuddyBuddy aggregates publicly available trial information.