Evaluating the effects of PCSK-9 inhibition on blood flow in patients with stable coronary disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the impact of PCSK-9 inhibition using Evolocumab on coronary blood flow in patients with stable coronary artery disease. It is a single-arm, open-label study that will recruit 50 participants who will undergo imaging with PET and coronary computed tomography angiography before and after 12 months of treatment. A parallel control group of 15 stable CAD patients will also be included to compare changes in myocardial blood flow and inflammatory biomarkers. The study seeks to provide insights into how PCSK-9 inhibition may improve cardiovascular outcomes beyond just reducing plaque burden.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Diana Lopez, MD — Brigham and Women's Hospital
• Study coordinator: Diana Lopez, MD
• Email: dlopez@bwh.harvard.edu
• Phone: 617-525-8268

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.