The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Nov 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Evolocumab, which helps lower cholesterol levels, on blood flow in the heart for patients with stable coronary artery disease (CAD). The researchers want to see how this treatment can improve the heart's blood flow over a year. To do this, they will use special imaging tests to measure changes in heart blood flow and plaque buildup in the arteries before and after treatment. The trial will include 50 participants who meet specific health criteria, and there will also be a smaller group of 15 control participants who will undergo similar tests but will not receive the medication.

To be eligible for the trial, participants need to be at least 50 years old for men and 55 for women, have a certain level of bad cholesterol (LDL-C), and have stable CAD defined by specific heart imaging results or tests. They should not have had a recent heart attack or stroke, among other health issues. Participants can expect to undergo imaging tests at the start and after 12 months, and they will be monitored throughout the study. It's important to know that if someone has a latex allergy, is not comfortable with injections, or has slightly lower cholesterol levels, they may still join the control group for comparison purposes.

Gender

ALL

Eligibility criteria

• 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 before randomization) defined as one or more of the following:
• • 1. Abnormal nuclear perfusion imaging
• • 1. At least moderate ischemia involving \>10% of the LV myocardium or
• • 2. Global coronary flow reserve (CFR) \<1.8 or
• • 3. Stress myocardial blood flow (MBF) \<1.8
• • 2. Abnormal coronary angiography (invasive coronary angiography or coronary computed tomography)
• • 1. ≥ 50% stenosis in ≥ 2 coronary vessels or
• • 2. Diffuse atherosclerosis in a 3-vessel distribution
• • 3. Elevated coronary calcium score
• • 1. CAC \>100 + \>1 ASCVD risk factor
• • 2. CAC \>300
• • If the patient is on a statin they must be on a stable dose for at least 3 months prior to enrollment.
• 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-IV for 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.