Heart drug study aims to boost tiny vessel blood flow
NCT ID NCT05152888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a cholesterol-lowering drug called Evolocumab can improve blood flow in the small blood vessels of the heart. About 50 people with stable coronary artery disease will get the drug for 12 months and have heart scans before and after. A small control group of 15 people will not get the drug but will have the same scans. The goal is to see if the drug helps the heart get more blood during stress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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