Actively Recruiting
Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease and Aortic Valve Disease
Led by East and North Hertfordshire NHS Trust · Updated on 2023-11-13
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between lipoprotein(a) [Lp(a)] levels in the blood and the body's 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 Lp(a) with medications like PCSK9 inhibitors or inclisiran can improve clot dissolution and potentially lower the risk of heart attacks and strokes. Elevated Lp(a) 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. Lp(a) 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 Lp(a) levels. The study will review thrombotic status and Lp(a) 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.
CONDITIONS
Brief Title
Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years or over
- Patients eligible for treatment with either a PCSK9 inhibitor or inclisiran
- Patients diagnosed with moderate or severe calcific aortic stenosis based on non-enhanced Cardiac CT scan
- Willing and able to understand the Participant Information Sheet and provide informed consent
- Agree to comply with blood sample collection for assessments
- Do not meet any exclusion criteria
You will not qualify if you...
- Unable to provide valid informed consent
- Under 18 years of age
- Significant neurological, liver, kidney, endocrine, digestive, lung, bleeding, metabolic, or other serious disease likely to affect the study
- History or signs of substance abuse or psychiatric disease
- Alcohol consumption above 14 units per week
- Any significant illness within four weeks before screening
- Major bleeding disorders or abnormal blood counts
- Currently enrolled in another investigational device or non-licensed drug trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment at baseline
Participants undergo blood tests to assess thrombotic status and measure Lipoprotein(a) levels. This includes the Global Thrombosis Test, thromboelastography, and immunoturbidimetric assays.
1 visit (in-person)
Duration - 3 to 6 months
Participants eligible for treatment with PCSK9 inhibitors or inclisiran have follow-up assessments 3 to 6 months after starting treatment to evaluate changes in thrombotic status and Lipoprotein(a) levels. Participants with moderate or severe aortic valve calcification have a single assessment.
1 to 2 visits depending on treatment eligibility
Trial Site Locations
Total: 1 location
1
East and North Herts NHS Trust
Stevenage, United Kingdom
Actively Recruiting
Research Team
J
Joshua H Leader, MBChB, BSc
D
Diana A Gorog, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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