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

Study acronym: EMPOWER
StatusRecruiting
PhasePhase 4
Started2022-03-03
View on ClinicalTrials.gov ↗

Amendment history

2025-11-03
Study Status v5
Primary completion date2025-12-31→2027-03-31
Completion date2025-12-31→2027-12-31
2024-08-07
Study Status, Sponsor/Collaborators, Study Design, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2023-06-20
Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v3
Enrollment target35→50
Study arms1→2
Eligibility criteria+362 characters
Intervention Group: Inclusion Criteria: Age: ≥ 50 (men) or ≥ 55 (women) Low-dens [...] 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 t [...]
Study description-96 characters
[...] PCSK-9 inhibition, the investigators will assess changes in endothelial function and inflammatory biomarkers. The findings of this translational [...] the comprehensive effects of Evolocumab on tissue perfusion, endothelial function, and microvascular function in a high-risk population. As su [...] the improvement in myocardial blood flow will correlate with an improvement in endothelial cell function and a reduction in inflammatory biomarkers, and not simply an improvement in coronary epicardial plaque burden.
2022-11-01
Not Yet Recruiting→Recruiting Study Status, Study Description, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-01-01→confirmed 2022-03-03
Study sites0→1
Eligibility criteriarevised
Inclusion Criteria: Age: ≥ 50 (men) or ≥ 55 (women) Low-density lipoprotein cholesterol (LDL-C) >≥ 9070 mg/dL Stable coronary artery disease (without plan to under [...] asive coronary angiography or coronary computed tomography) >≥ 50% stenosis in >≥ 2 coronary vessels or Diffuse atherosclerosis in a 3-vessel [...]
2021-12-16
Study Status, Study Description v1
Study description+45 characters
WeThe investigators propose an open-label investigator-initiated trial to direc [...] hich myocardial blood flow improves with PCSK-9 inhibition, wethe investigators will assess changes in endothelial function and inflammator [...] aphy (PET) in patients with stable coronary artery disease. WeThe investigators postulate that the improvement in myocardial blood flow wil [...]
2021-11-29
Original filing
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.
Trial Details
NCT Number NCT05152888
Lead Sponsor Brigham and Women's Hospital
Conditions Stable Coronary Disease
Enrollment 50 participants
Start Date 2022-03-03
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-04