Stable Coronary DiseasePhase 4EMPOWERNCT05152888
The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
A Phase 4 study testing Evolocumab in people with Stable Coronary Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Stable Coronary Disease
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Diana Lopez, MD, 617-525-8268, dlopez@bwh.harvard.edu
Leanne Barrett, 617-732-4719, lbarrett11@bwh.harvard.edu
About this study
Official title: The Impact of Pcsk-9 Inhibition on PET Coronary Flow Reserve in Patients at High Cardiovascular Risk (EMPOWER Study)
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.
Read the detailed description
The investigators propose an open-label investigator-initiated trial to directly test whether PCSK-9 inhibition with Evolocumab in patients with stable CAD improves PET CFR and stress MBF. To further elucidate the possible mechanisms by which myocardial blood flow improves with PCSK-9 inhibition, the investigators will assess changes in inflammatory biomarkers. The findings of this translational study will provide a physiological read-out of the comprehensive effects of Evolocumab on tissue perfusion and microvascular function in a high-risk population. As such, these data would serve to provide a mechanistic explanation for why Evolocumab may reduce cardiovascular events beyond a reduction in plaque burden and composition.
The central hypothesis of this study is that PCSK-9 inhibition will quantitatively improve myocardial blood flow as measured by positron emission tomography (PET) in patients with stable coronary artery disease. The investigators postulate that the improvement in myocardial blood flow will correlate with a reduction in inflammatory biomarkers, and not simply an improvement in coronary epicardial plaque burden.
- Conditions
- Stable Coronary Disease
- Being tested
- Evolocumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called Repatha
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.
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | 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. Receives: Drug: Evolocumab |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve
Change in global coronary flow reserve (CFR) after 12 months of therapy with Evolocumab
Measured: Change (from baseline) in global CFR, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy.
Stress Myocardial Blood Flow (MBF)
Change in stress Myocardial Blood Flow (MBF) after 12 months of therapy with Evolocumab
Measured: Change (from baseline) in stress MBF, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy.
Secondary outcomes (1)
Total Perfusion Deficit (TPD)
Change in Total Perfusion Deficit (TPD) after 12 months of therapy with Evolocumab
Measured: Change (from baseline) in TPD, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start3 Mar 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study protocol is an open label pilot study with a parallel control group.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana M. Lopez, MD, Brigham and Women's Hospital
- Investigators
- Diana Lopez, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152888
- Sponsor's protocol ID
- 2021P003360
- Acronym
- EMPOWER
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2021
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pcsk-9 Inhibition on PET Coronary Flow Reserve in Patients at High Cardiovascular Risk (EMPOWER Study)
- ClinicalTrials.gov ID
- NCT05152888
- Acronym / sponsor ID
- EMPOWER / 2021P003360
- Conditions
- Stable Coronary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose an open-label investigator-initiated trial to directly test whether PCSK-9 inhibition with Evolocumab in patients with stable CAD improves PET CFR and stress MBF. To further elucidate the possible mechanisms by which myocardial blood flow improves with PCSK-9 inhibition, the investigators will assess changes in inflammatory biomarkers. The findings of this translational study will provide a physiological read-out of the comprehensive effects of Evolocumab on tissue perfusion and microvascular function in a high-risk population. As such, these data would serve to provide a mechanistic explanation for why Evolocumab may reduce cardiovascular events beyond a reduction in plaque burden and composition.
The central hypothesis of this study is that PCSK-9 inhibition will quantitatively improve myocardial blood flow as measured by positron emission tomography (PET) in patients with stable coronary artery disease. The investigators postulate that the improvement in myocardial blood flow will correlate with a reduction in inflammatory biomarkers, and not simply an improvement in coronary epicardial plaque burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study protocol is an open label pilot study with a parallel control group.
| Arm | Type | Receives |
|---|---|---|
| Evolocumab | Experimental | Drug: EvolocumabInformed 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- If the patient is on a statin they must be on a stable dose for at least 3 months prior to enrollment.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: RepathaEvolocumab 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. | Drug | Evolocumab |
Primary outcome
Coronary Flow Reserve
Time frame: Change (from baseline) in global CFR, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy.
Change in global coronary flow reserve (CFR) after 12 months of therapy with Evolocumab
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.
Change in stress Myocardial Blood Flow (MBF) after 12 months of therapy with Evolocumab
1 secondary outcome
Total Perfusion Deficit (TPD)
Time frame: Change (from baseline) in TPD, as measured by PET imaging at 52 weeks after initiation of Evolocumab therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Lopez, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab in people with Stable Coronary Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Lopez, MD (617-525-8268, dlopez@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.