Fact CheckerSign in

NCT05152888RecruitingPhase 4

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

The Impact of Pcsk-9 Inhibition on PET Coronary Flow Reserve in Patients at High Cardiovascular Risk (EMPOWER Study)

Source: ClinicalTrials.gov · Last updated 4 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The study protocol is a single-arm, open label pilot study designed to evaluate the impact of PCSK-9 inhibition on coronary blood flow in patients with stable coronary artery disease. Patients with stable coronary artery disease will be recruited from the BWH Cardiovascular Medicine clinic and/or from the BWH Nuclear Cardiology Laboratory. A target sample size of 50 participants will undergo imaging with N-13 ammonia or Rubidium-82 positron emission tomography (PET) and coronary computed tomography angiography (CCTA) before and after 12 months of PCSK-9 inhibition with Evolocumab to assess changes in myocardial blood flow, and plaque volume. To help account for physiological changes that may occur in myocardial blood flow and inflammatory biomarkers during the study period, we will also recruit a parallel control group of stable CAD patients who will undergo similar baseline and 12-month imaging and biomarker assessment. We plan to recruit 15 patients in the parallel control group.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
50 (estimated)
First submitted
29 Nov 2021
Start date
3 Mar 2022
Primary completion date
31 Mar 2027
Lead sponsor
Brigham and Women's Hospital
NCT number
NCT05152888

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 50
  • From 3 Mar 2022 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • CABG \< 3 months prior to screening
  • Current use of a PCSK-9 inhibitor

Other illness

  • History of myocardial infarction or stroke
  • History of cardiac transplantation
  • History of infiltrative or hypertrophic cardiomyopathy
  • Severe valvular disease
  • 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.

Lab values

  • LV ejection fraction \< 40% or New York Heart Failure Association (NYHA) class III-IV for angina and/or dyspnea.
  • Fasting triglycerides \> 500 mg/dL
  • GFR ˂ 30 mL/min/1.73 m²

Other

  • Homozygous familial hypercholesterolemia
  • Uncontrolled or recurrent ventricular tachycardia
  • Currently pregnant or breastfeeding
  • Contraindication to receive vasodilator agent

Who the study is looking for

  • 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:
    • 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 coronary computed 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 months prior to enrollment.

Criteria the registry did not label

  • Intervention Group:

Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status		BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.