Effects of PCSK9 Inhibition on Inflammation in Heart Disease
ImmuNomodulatory EffectS of PCSK9 Inhibition: A TaRgeted Molecular Imaging AppRoach
This study is testing if a new type of cholesterol-lowering medication can also help reduce inflammation in the arteries of people with heart disease who are already taking strong statins.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | evolocumab, alirocumab, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05720156 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the immunomodulatory effects of PCSK9 inhibitors on patients with a history of atherosclerotic cardiovascular disease (ASCVD) who are already on high-intensity statin therapy. It aims to understand how these inhibitors, which lower LDL cholesterol levels, may also reduce arterial inflammation, potentially impacting the risk of further cardiovascular events. Participants will undergo 99mTc-tilmanocept SPECT/CT scanning to assess inflammation levels. The study focuses on patients who have initiated treatment with either evolocumab or alirocumab.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a history of ASCVD who have been on high-intensity statin therapy for at least six months and are starting PCSK9 inhibition.
Not a fit: Patients without a history of ASCVD or those currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into new treatment strategies that reduce inflammation and improve outcomes for patients with cardiovascular disease.
How similar studies have performed: Other studies have shown promising results with PCSK9 inhibitors in reducing cardiovascular events, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 85 years of age * CASE PARTICIPANTS ONLY: History of ASCVD (including a history of coronary artery disease, carotid artery disease, peripheral artery disease, acute coronary syndrome, percutaneous coronary intervention, coronary bypass surgery, carotid endarterectomy, stroke or TIA) * CASE PARTICIPANTS ONLY: High-intensity statin therapy for at least 6 months prior enrollment and without an interruption of \>1 month * CASE PARTICIPANTS ONLY: Initiation of PCSK9 inhibition with either evolocumab or alirocumab (and not inclisiran - PSCK9 inhibition through small interfering RNA) Exclusion Criteria: * pregnancy or breastfeeding * CONTROL PARTICIPANTS ONLY: No known history of ASCVD (including a history of coronary artery disease, carotid artery disease, peripheral artery disease, acute coronary syndrome, percutaneous coronary intervention, coronary bypass surgery, carotid endarterectomy, stroke or TIA) * current treatment with prescription, systemic (oral, IV, IM or intra-articular) steroids or anti-inflammatory/immune suppressant medical therapies (excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune/inflammatory diseases (psoriasis, RA, IBD, lupus), post-transplant care, asthma, or pain syndromes * use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \> 7 days within the past 1 month * use of IV, IM or intra-articular steroids or IV, IM or intra-articular anti-inflammatory/immune suppressant medication within the past 3 months * Any prior use of PCSK9 inhibitors including both monoclonal antibodies or small interfering RNA * CONTROL PARTICIPANTS ONLY: use of cholesterol lowering therapy (including statins, ezetimibe, bempedoic acid, PCSK9 inhibitors including both monoclonal antibodies or small interfering RNA, niacin, fibrates) or other lipid lowering agents associated with ASCVD risk reduction such as Vascepa. Cholesterol lowering therapies that that predominantly target triglycerides including over the counter omega-3 fatty acids and Lovaza are permitted. * known allergy to dextrans and/or DTPA and/or radiometals * significant radiation exposure (\>2 CT angiograms) received within the past 12 months * concurrent enrollment in another research study judged by the study investigators to interfere with the current study
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Mabel Toribio
- Email: mptoribio@mgh.harvard.edu
- Phone: 617-724-2826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.