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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04043026
Other study ID # UoL001456 - 4843
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 26, 2019
Est. completion date August 1, 2022

Study information

Verified date August 2022
Source University of Liverpool
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is designed to investigate the role of lipids/lipoproteins as a potential cause for the harmful changes seen in fibrin clot properties with renal dysfunction and atrial fibrillation


Description:

This is a prospective, observational, blinded study that will be conducted in two parts. The first study will assess the relationship between lipids/lipoproteins and fibrin clot properties among anticoagulated atrial fibrillation patients with and without renal dysfunction. The second study will assess the effects of statin therapy on lipids/lipoproteins and fibrin clot properties in anticoagulated atrial fibrillation patients with renal dysfunction. Renal dysfunction is defined as an estimated glomerular filtration rate below 50 ml/min/1.73m2 for the purposes for this trial.


Recruitment information / eligibility

Status Terminated
Enrollment 56
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 6.1 Inclusion criteria WP1: - On anticoagulation therapy - Informed consent obtained WP2: - Not receiving statins prior to recruitment - Diagnosed atrial fibrillation - On anticoagulation therapy - Estimated glomerular filtration rate of <50 ml/min/1.73m2 - Informed consent obtained 6.2 Exclusion criteria - Age <18 years - Severe mitral stenosis or presence of metallic prosthetic valve - Active or recent malignancy (<6 months) - Active immunological disease - Connective tissue disease - Chronic liver disease - Recent or chronic serious infection - Chronic inflammatory disease - Known haemophilia or thrombophilia - Active bleeding - Untreated hypothyroidism or hyperthyroidism - Recent surgery (<3 months) - Familial lipid disorders - Concurrent use of steroids - Dietary supplements known to influence lipids - Contraindications/inability/unwillingness to commence statin (WP2)

Study Design


Intervention

Drug:
Statin
Any statin therapy

Locations

Country Name City State
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom Liverpool University Hospitals NHS Foundation Trust Liverpool

Sponsors (5)

Lead Sponsor Collaborator
University of Liverpool Liverpool Centre for Cardiovascular Science, Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool John Moores University, University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test Lag time, maximum absorbance, time to maximum absorbance and clot lysis time At baseline
Primary WP1: Fibrin permeation analysis using validated test Permeation constant (Ks) At baseline
Primary WP1: Low density lipoprotein fractions Measure of low density lipoprotein subclass fractions At baseline
Primary WP1: Oxidised low density lipoprotein Measure of oxidised low density lipoprotein At baseline
Primary WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test Lag time, maximum absorbance, time to maximum absorbance and clot lysis time At baseline and after 6 weeks of statin therapy
Primary WP2: Fibrin permeation analysis using validated test Permeation constant (Ks) At baseline and after 6 weeks of statin
Primary WP2: Low density lipoprotein fractions Measure of low density lipoprotein subclass fractions At baseline and after 6 weeks of statin
Primary WP2: Oxidised low density lipoprotein Measure of oxidised low density lipoprotein At baseline and after 6 weeks of statin
Secondary WP1: Scanning electron microscopy Qualitative assessment of fibril indices At baseline
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