Assessing Lipoprotein(a) and Fibrinolysis in Heart Disease
Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
This study is testing whether lowering a specific cholesterol called Lipoprotein(a) with certain medications can help improve the body's ability to dissolve blood clots in people with heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Locations | 1 site (Stevenage) |
| Trial ID | NCT06126367 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with moderate to severe calcific aortic stenosis who are eligible for treatment with PCSK9 inhibitors or inclisiran.
Not a fit: Patients under 18 or those with significant comorbidities that may confound study results are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies that improve clot lysis and reduce cardiovascular risks for patients with elevated Lipoprotein(a).
How similar studies have performed: While previous studies have explored the role of Lipoprotein(a) in cardiovascular disease, this specific approach of enhancing fibrinolysis through targeted therapies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stevenage
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.