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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) \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03872401). StuddyBuddy aggregates publicly available trial information.