Status:
RECRUITING
Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
Lead Sponsor:
East and North Hertfordshire NHS Trust
Conditions:
Atherosclerosis
Aortic Valve Disease
Eligibility:
All Genders
18+ years
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 treatme...
Detailed Description
The risk of a clot forming in a blood vessel, which can cause a heart attack or stroke, is determined partly by how "sticky" the blood is and partly by the effectiveness of the natural defences in the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06126367
Start Date
October 20 2023
End Date
October 1 2027
Last Update
November 13 2023
Active Locations (1)
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1
East and North Herts NHS Trust
Stevenage, United Kingdom