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Contact Information:

Diana A Gorog, MD, PhD 01707247512
d.gorog@imperial.ac.uk


Joshua H Leader, MBChB, BSc 07376188768
joshua.leader@nhs.net


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Be Part of Research - Trial Details - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
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Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease

Recruiting

Open to: ALL

Age: 18.0 - N/A

Stevenage

Medical Conditions

Atherosclerosis
Aortic Valve Disease

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2023 Oct 2027

OBSERVATIONAL

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : The Global Thrombosis Test (Thromboquest Limited, UK) is an in vitro method imitating high shear stress conditions akin to that which exist in a severely stenosed artery. The test measures platelet reactivity (occlusion time) and endogenous fibrinolysis time (lysis time).

Thromboelastography is a technique that assesses the whole process of clotting and its viscoelastic properties, from the initial activation and aggregation of platelets, to the role of thrombin and finally the stability of the formed clot, as a measure of fibrinolytic resistance.

Plasma will be stored for subsequent analysis of other thrombotic, fibrinolytic, inflammatory and coagulation markers as deemed appropriate.

For patients deemed eligible for treatment with either a PCSK9i or inclisiran, this will be assessed prior to commencing treatment and also 3-6 months after starting treatment.

This will only be assessed once for patients with moderate or severe aortic valve calcification.

Intervention Arm Group : Patients identified as eligible for treatment with either a PCSK9i or inclisiran;Patients with moderate or severe aortic calcification identified by non-enhanced cardiac CT scan;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Lp(a) will be measured by particle enhanced immunotubidimetricassay. Human lipoprotein (a) agglutinates with latex particles coated with anti-Lp(a) antibodies. The precipitate is determined turbidimetrically at 800 / 660 nm. The platform employed will be the Roche® Immunoassay Analyser (Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim). Traceability: This method has been standardized against the IFCC (International Federation of Clinical Chemistry) reference material SRM2B for nmol/L.

For patients deemed eligible for treatment with either a PCSK9i or inclisiran, this will be assessed prior to commencing treatment and also 3-6 months after starting treatment.

This will only be assessed once for patients with moderate or severe aortic valve calcification.

Intervention Arm Group : Patients identified as eligible for treatment with either a PCSK9i or inclisiran;Patients with moderate or severe aortic calcification identified by non-enhanced cardiac CT scan;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • East and North Herts NHS Trust
    Stevenage

Joshua H Leader, MBChB, BSc 07376188768
joshua.leader@nhs.net


Diana A Gorog, MD, PhD 01707247512
d.gorog@imperial.ac.uk



The study is sponsored by East and North Hertfordshire NHS Trust



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Read full details for Trial ID: NCT06126367
Last updated 06 November 2023

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