Study of Lipoproteina Levels and Natural Clot Dissolving in Heart and Aortic Valve Disease Using PCSK9 Inhibitors or Inclisiran

What this Trial Is About

Researchers are investigating the relationship between lipoproteina Lpa levels in the blood and the bodys natural ability to dissolve blood clots, called endogenous fibrinolysis. This study focuses on patients with atherosclerotic cardiovascular disease or aortic valve disease, aiming to understand if reducing Lpa with medications like PCSK9 inhibitors or inclisiran can improve clot dissolution and potentially lower the risk of heart attacks and strokes. Elevated Lpa is considered a risk factor that may impair fibrinolysis, and new cholesterol-lowering treatments have shown promise in reducing these levels. The study involves assessing patients who are eligible for treatment with PCSK9 inhibitors or inclisiran and those diagnosed with moderate or severe aortic valve calcification. Blood clotting and fibrinolysis will be measured using specialized tests such as the Global Thrombosis Test and thromboelastography. Lpa levels will be measured through immunoassays. Assessments will occur before starting treatment and again 3 to 6 months after treatment initiation for those receiving therapy. Patients with aortic valve calcification will be assessed once. During participation, blood samples will be collected to analyze clotting and fibrinolysis markers, as well as Lpa levels. The study will review thrombotic status and Lpa levels at 3 to 6 months to evaluate changes. This observational study involves monitoring without altering usual care. The total duration of involvement varies, depending on treatment eligibility and follow-up timing. The research is sponsored by the East and North Hertfordshire NHS Trust to better understand clotting risks and treatment responses in cardiovascular patients.

Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease