Clinical Research Directory
Browse clinical research sites, groups, and studies.
In Vitro Demonstration of Direct Platelet-Related Effects of PCSK9 Enzyme
Sponsor: LifeBridge Health
Summary
Proprotein convertase subtilisin/kexin type 9 (PCSK9) has evolved as a pivotal enzyme in lipid metabolism and therapeutic target for hypercholesterolemia and atherosclerotic cardiovascular disease (CVD). Furthermore, research from in-vitro and in-vivo animal models suggest that the inhibition of PCSK9 expression may suppress platelet activation, and systemic inflammation thereby reducing thrombotic risk. Taken together, these data support the lower rates of myocardial infarction, stroke, and coronary revascularization in subjects with increased CVD risk in clinical trials with alirocumab (Praluent) and evolocumab (Repatha) as compared to placebo. The main aim of this single center, exploratory in-vitro evaluation is to investigate the direct role of PCSK9 on platelet activation and aggregation using blood collected from a diverse population of antiplatelet naïve healthy volunteers (n=40) and subjects with CVD risk factors (n=40) between the 18-50 years of age. All procedures including consenting, collection of clinical data, and lab processing will occur at the Sinai Center for Thrombosis Research. The results of this study will provide a better understanding of cardioprotective effects of PCSK9 inhibition beyond lipid lowering.
Official title: Evaluation of PCSK9 Enzyme in Non-Cholesterol Biological Pathways: In Vitro Demonstration of Direct Platelet-Related Effects of PCSK9 Enzyme
Key Details
Gender
All
Age Range
18 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2024-12-01
Completion Date
2025-12-30
Last Updated
2024-11-06
Healthy Volunteers
Yes
Conditions
Interventions
PCSK9 Antibody, PCSK9 Enzyme
In-vitro demonstration of the direct effect if the PCSK9 enzyme on platelets. The study will use commercially available recombinant PCSK9 enzyme to promote platelet activity and the PCSK9 antibody to inhibit activity. In each patient, platelet function testing will occur in the absence of PCSK9 enzyme, after the addition of PCSK9 enzyme, and after the addition of both PCSK9 enzyme and antibody reagent to the blood sample prior to testing.