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RECRUITING
NCT05152888
PHASE4

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-03-03

Completion Date

2027-12-31

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States