Evolocumab for Coronary Heart Disease
(EMPOWER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on a statin, you must be on a stable dose for at least 3 months before joining the study.
How is the drug Evolocumab unique for treating coronary heart disease?
Evolocumab is unique because it is a monoclonal antibody that targets a specific protein (PCSK9) to help the liver remove more LDL cholesterol from the blood, which is different from traditional treatments like statins. It is administered through an injection, either every two weeks or once a month, and is particularly useful for patients who cannot tolerate statins or need additional help lowering their cholesterol.12345
Who Is on the Research Team?
Diana Lopez, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 50 (men) or 55 (women) with stable coronary artery disease and LDL cholesterol ≥70 mg/dL. They must not be planning revascularization soon, have been on a steady statin dose for 3+ months if applicable, and meet certain criteria indicating heart issues. Excluded are pregnant/breastfeeding individuals, those with severe heart conditions, kidney failure, contraindications to vasodilators, recent major cardiac events or procedures, specific genetic disorders affecting cholesterol levels, severe heart failure or angina.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline rest/stress cardiac PET scan along with CCTA
Treatment
Participants receive PCSK-9 inhibition with Evolocumab for 12 months
Follow-up
Participants undergo final PET scan and CCTA to assess changes in myocardial blood flow and plaque volume
What Are the Treatments Tested in This Trial?
Interventions
- Evolocumab
Evolocumab is already approved in United States, European Union for the following indications:
- To reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease
- Familial hypercholesterolemia
- High-risk patients with LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL on maximally tolerated statin therapy ± ezetimibe
- Primary hypercholesterolaemia and mixed dyslipidaemia
- Homozygous familial hypercholesterolaemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor