Phase
Condition
N/ATreatment
Evolocumab
Clinical Study ID
Ages 50-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Intervention Group:
Inclusion Criteria:
Age: ≥ 50 (men) or ≥ 55 (women)
Low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL
Stable coronary artery disease (without plan to undergo revascularization beforerandomization) defined as one or more of the following:
Abnormal nuclear perfusion imaging
At least moderate ischemia involving >10% of the LV myocardium or
Global coronary flow reserve (CFR) <1.8 or
Stress myocardial blood flow (MBF) <1.8
Abnormal coronary angiography (invasive coronary angiography or coronarycomputed tomography)
≥ 50% stenosis in ≥ 2 coronary vessels or
Diffuse atherosclerosis in a 3-vessel distribution
Elevated coronary calcium score
CAC >100 + >1 ASCVD risk factor
CAC >300
- If the patient is on a statin they must be on a stable dose for at least 3 monthsprior to enrollment.
Exclusion
Exclusion Criteria:
History of myocardial infarction or stroke
CABG < 3 months prior to screening
Homozygous familial hypercholesterolemia
History of cardiac transplantation
LV ejection fraction < 40% or New York Heart Failure Association (NYHA) class III-IVfor angina and/or dyspnea.
History of infiltrative or hypertrophic cardiomyopathy
Severe valvular disease
Uncontrolled or recurrent ventricular tachycardia
Fasting triglycerides > 500 mg/dL
GFR ˂ 30 mL/min/1.73 m²
Current use of a PCSK-9 inhibitor
Currently pregnant or breastfeeding
Contraindication to receive vasodilator agent
Latex allergy
Parallel Control Group:
Patients will be invited to participate in the parallel control group if they meet study criteria, but 1) have a latex allergy and cannot use the Evolocumab autoinjector 2) LDL-C is just below the enrollment criteria (LDL 60-69), or 3) meet study criteria but prefer to not take an injectable medication at this time.
Study Design
Study Description
Connect with a study center
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
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