Actively Recruiting

Age: 18Years +
All Genders
NCT06126367

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

Led by East and North Hertfordshire NHS Trust · Updated on 2023-11-13

180

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 18 years or over
  • Patients eligible for treatment with PCSK9 inhibitors or inclisiran
  • 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
  • Agree to comply with blood sample collection for assessments
  • Do not meet any exclusion criteria
Not Eligible

You will not qualify if you...

  • Unable to provide valid informed consent
  • Patients under 18 years of age
  • Significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, hemorrhagic, metabolic or other disease likely to affect study results
  • History or signs of substance abuse or psychiatric disease
  • Alcohol consumption above 14 units per week
  • Any significant illness during the 4 weeks before screening
  • Major bleeding disorders or blood abnormalities (platelets < 70 x 109/l, Hb < 8 g/dl, INR > 1.4, APTT > 2 times upper normal limit, leucocyte count < 3.5 x 109/l, neutrophil count < 1 x 109/l)
  • Currently enrolled in another investigational device or non-licensed drug trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

East and North Herts NHS Trust

Stevenage, United Kingdom

Actively Recruiting

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Research Team

J

Joshua H Leader, MBChB, BSc

CONTACT

D

Diana A Gorog, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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