Recruiting

Evolocumab

Sponsor:

Brigham and Women's Hospital

Code:

NCT05152888

Conditions

Stable Coronary Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Evolocumab

Study Details

Brief summary:

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.

Conditions

Stable Coronary Disease

Study ID

NCT05152888

Start date

Mar 3, 2022

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Evolocumab

Informed consent will be obtained from study participants willing to participate in EMPOWER. Study participants will then undergo the baseline rest/stress cardiac PET scan along with CCTA. The final PET scan and CCTA will occur at 12 months after the intervention.

no intervention: Control

Informed consent will be obtained from study participants willing to participate in EMPOWER. Study participants will then undergo the baseline rest/stress cardiac PET scan along with CCTA. The final PET scan and CCTA will occur at 12 months after the baseline.

Interventions

Evolocumab

Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9). Evolocumab was FDA approved in 2015 for the treatment of hyperlipidemia and subsequently approved in 2017 for the prevention of stroke and heart attack. 140mg single use SureClick autoinjector that is administered subcutaneously once every 2 weeks.

Primary outcome measure

  • Coronary Flow Reserve [ Time Frame: Change (from baseline) in global CFR, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy. ]
  • Stress Myocardial Blood Flow (MBF) [ Time Frame: Change (from baseline) in stress MBF, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy. ]

Central Contacts and Locations

Central contacts

Diana Lopez, MD

617-525-8268dlopez@bwh.harvard.edu

Leanne Barrett

617-732-4719lbarrett11@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Diana Lopez, MD

617-525-8268dlopez@bwh.harvard.edu

Leanne Barrett

617-732-4719lbarrett11@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-11-04.