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 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

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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Page 1 of 1 (1 locations)

1

East and North Herts NHS Trust

Stevenage, United Kingdom