NCT06126367 Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
| NCT ID | NCT06126367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | East and North Hertfordshire NHS Trust |
| Condition | Atherosclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2023-10-20 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prior studies have shown that impaired endogenous fibrinolysis is a novel, independent cardiovascular risk factor in patients with myocardial infarction and there is currently no known chronic treatment to enhance endogenous fibrinolysis. To date, no therapies have been able to sufficiently reduce Lp(a) and therefore it was considered to be a non-modifiable cardiovascular risk factor. New data, however, has shown that PCSK9 inhibitors and inclisiran (medication that you have been deemed eligible for in order to help further reduce your cholesterol levels) to reduce Lp(a) levels by approximately 20-25%. The aim of this study to is to assess: 1. if there is an association between raised Lp(a) level in blood and the effectiveness of endogenous fibrinolysis (lysis time). 2. whether lowering Lp(a) with PCSK9i or inclisiran can enhance endogenous fibrinolysis
Eligibility 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
Contact & Investigator
Diana A Gorog, MD, PhD
PRINCIPAL INVESTIGATOR
East and North Hertfordshire NHS Trust
Frequently Asked Questions
Who can join the NCT06126367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atherosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06126367 currently recruiting?
Yes, NCT06126367 is actively recruiting participants. Contact the research team at joshua.leader@nhs.net for enrollment information.
Where is the NCT06126367 trial being conducted?
This trial is being conducted at Stevenage, United Kingdom.
Who is sponsoring the NCT06126367 clinical trial?
NCT06126367 is sponsored by East and North Hertfordshire NHS Trust. The principal investigator is Diana A Gorog, MD, PhD at East and North Hertfordshire NHS Trust. The trial plans to enroll 180 participants.