In Vitro Demonstration of Direct Platelet-Related Effects of PCSK9 Enzyme

Launched by LIFEBRIDGE HEALTH · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specific enzyme called PCSK9 on blood platelets, which are important for blood clotting. Researchers want to learn how PCSK9 might influence platelet activity and whether this could help reduce the risk of heart problems, like heart attacks and strokes, especially in people with certain health risks. The trial will involve two groups of volunteers: 40 healthy individuals and 40 people who have risk factors for heart disease, such as high cholesterol or diabetes. All participants will be between 18 and 50 years old.

To take part in the study, healthy volunteers must not have any conditions that could affect platelet function, while those with cardiovascular risk factors need to have at least three specific health issues, such as being overweight or having a family history of heart disease. Participants will undergo various procedures at the Sinai Center for Thrombosis Research, where they will provide blood samples, and the researchers will analyze the effects of PCSK9. This study is not yet recruiting participants, but it aims to enhance our understanding of how PCSK9 might protect against heart disease beyond just lowering cholesterol levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy subjects (n=40): 18-50 years old male and female subjects without any conditions or taking any agents or food supplements that may influence platelet function as determined by the study principal investigator.
• * Subjects with CV risk factors (n=40): 18-50 years old male and female subjects with at least three of the following CV risk factors:
• • History of hypercholesterolemia, hypertension, overweight, current smoker, prediabetes or diabetes who are only on metformin and insulin, and family history of coronary artery, peripheral artery, or cerebrovascular disease.
• • Overweight is defined as subjects with BMI ≥25 kg/m2 (https://www.heart.org/en/healthy-living/healthy-eating/losing-weight/bmi-in-adults).
• • Diabetes is defined as haemoglobin (Hb)A1c ≥6.5%, prediabetes =5.7%-6.4%) (https://diabetes.org/about-diabetes/diagnosis)
• Exclusion Criteria:
• • Subjects with Diabetes mellitus, who are on GLP-1 agonists or SGLT2 inhibitors.
• • Subjects on high dose statin therapy or PCSK9 therapy.
• • Prior coronary of cerebrovascular event requiring intervention.
• • Use of any antiplatelet or anticoagulant therapy within 14 days of enrollment.
• • Subjects with a history of chronic kidney disease, liver disease, pancreatitis, HIV, hepatitis, and active cancer, active infection, or any other medical condition or concomitant medications as determined by the investigator that may affect study results.
• • Pregnant