Assessing Lipoprotein(a) and Fibrinolysis in Heart Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between elevated Lipoprotein(a) levels and the effectiveness of the body's natural clot-dissolving mechanisms in patients with atherosclerosis and aortic valve disease. It aims to determine if lowering Lipoprotein(a) through medications like PCSK9 inhibitors or inclisiran can enhance endogenous fibrinolysis, potentially reducing the risk of heart attacks and strokes. Participants will undergo thrombotic assessments and blood tests to evaluate these factors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1\) Male and female patients aged 18 years or over

2\) i) Patients identified as eligible for treatment with either a PCSK9i or inclisiran ii) Patients diagnosed with moderate or severe calcific aortic stenosis based on non-enhanced Cardiac CT scan

3\) Willing and able to understand the Participant Information Sheet and provide informed consent

4\) The patient must agree to comply with the drawing of blood samples for the assessments

5\) The patient does not meet any of the exclusion criteria

Exclusion Criteria:

1. Inability to provide valid informed consent
2. Male and female patients aged \< 18 years of age
3. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses
4. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease
5. Alcohol consumption above recommended safe levels (i.e., more than 14 units per week) due to the potential effects of high alcohol levels on platelet reactivity
6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
7. Any major bleeding diathesis or blood dyscrasia (platelets \< 70 x 109/l, Hb \< 8 g/dl, INR \> 1.4, APTT \> x 2 upper normal limit, leucocyte count \< 3.5 x 109/l, neutrophil count \< 1 x 109/l)
8. Currently enrolled in an investigational device or non-licensed drug trial

Where it's running

• East and North Herts NHS Trust
  Stevenage, United Kingdom Recruiting

Study contacts

• Principal investigator: Diana A Gorog, MD, PhD — East and North Hertfordshire NHS Trust
• Study coordinator: Joshua H Leader, MBChB, BSc
• Email: joshua.leader@nhs.net
• Phone: 07376188768

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.