NCT05152888 The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk
| NCT ID | NCT05152888 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Stable Coronary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-03-03 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2022-03-03 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Diana Lopez, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT05152888 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Stable Coronary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05152888 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05152888 currently recruiting?
Yes, NCT05152888 is actively recruiting participants. Contact the research team at dlopez@bwh.harvard.edu for enrollment information.
Where is the NCT05152888 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05152888 clinical trial?
NCT05152888 is sponsored by Brigham and Women's Hospital. The principal investigator is Diana Lopez, MD at Brigham and Women's Hospital. The trial plans to enroll 50 participants.