TerminatedNot Applicable

The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function

Stopped: Slow recruitment due to COVID19 pandemic

United Kingdom56 participantsStarted 2019-09-26

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test

Timeframe: At baseline

WP1: Fibrin permeation analysis using validated test

Timeframe: At baseline

WP1: Low density lipoprotein fractions

Timeframe: At baseline

WP1: Oxidised low density lipoprotein

Timeframe: At baseline

WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test

Timeframe: At baseline and after 6 weeks of statin therapy

WP2: Fibrin permeation analysis using validated test

Timeframe: At baseline and after 6 weeks of statin

WP2: Low density lipoprotein fractions

Timeframe: At baseline and after 6 weeks of statin

Trial details

NCT IDNCT04043026

SponsorUniversity of Liverpool

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-01

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

WP1: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test

Timeframe: At baseline

WP1: Fibrin permeation analysis using validated test

Timeframe: At baseline

WP1: Low density lipoprotein fractions

Timeframe: At baseline

WP1: Oxidised low density lipoprotein

Timeframe: At baseline

WP2: Fibrin clot structure and function assessment using validated turbidity and fibrinolysis test

Timeframe: At baseline and after 6 weeks of statin therapy

WP2: Fibrin permeation analysis using validated test

Timeframe: At baseline and after 6 weeks of statin

WP2: Low density lipoprotein fractions

Timeframe: At baseline and after 6 weeks of statin