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

Recruiting now

Conditions studied: Atherosclerosis, Aortic Valve Disease

In brief

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

Key facts

Study ID

NCT06126367

Run by

East and North Hertfordshire NHS Trust

People needed

180

Starts

2023-10-20

Expected to finish

2027-10-01

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged 18 years or over
• 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
• Willing and able to understand the Participant Information Sheet and provide informed consent
• The patient must agree to comply with the drawing of blood samples for the assessments
• The patient does not meet any of the exclusion criteria

You may not qualify if…

• Inability to provide valid informed consent
• Male and female patients aged < 18 years of age
• 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
• The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease
• 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
• Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study
• 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)
• Currently enrolled in an investigational device or non-licensed drug trial

Where it is running

• East and North Herts NHS Trust — Stevenage, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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