Icosapent ethyl to arrest inflammation in the vessel wall Fat Attenuation Index (IRIS-FAI)
Research type
Research Study
Full title
Effect of icosapent ethyl on coronary Fat Attenuation Index score in high-risk, statin treated patients with established cardiovascular disease and elevated plasma triglycerides
IRAS ID
1009727
Contact name
Keith Boland
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN15140257
Research summary
Research Summary:
Cardiovascular disease is a general term for conditions affecting the heart or blood vessels. Although there have been improvements in the prevention and treatment of cardiovascular disease, it continues to be a major health concern globally.
Icosapent Ethyl (IPE), also known as ‘Vazkepa’, is an approved medication in the UK. This medication is given to people who have their cholesterol levels under control with statins but may still be at risk of cardiovascular disease for other reasons, such as high triglycerides (a type of fat in the blood). The risk that remains after statin use is known as “residual risk”.
People with high triglyceride levels are at greater risk of having a cardiovascular event, such as a heart attack or stroke. Clinical trials have shown that IPE can help lower this risk in people who are known to have cardiovascular disease and who have raised triglycerides. However, the way IPE works is not fully understood.
In this trial we would like to understand how IPE works. We will do this by assessing the effect of IPE on a marker known as the Fat Attenuation Index (FAI) score. FAI can detect inflammation on the coronary arteries using images from a CT scan (also known as a coronary CT angiography).
By testing the effect of IPE on the FAI score, we aim to better understand how IPE works and how it can be used to improve the health of people who are at risk of having a cardiovascular event.
The research will be carried out across approximately 6 different NHS hospital sites in the UK. We will identify high-risk individuals with established cardiovascular disease and raised triglyceride levels who are already receiving statins. The hypothesis is that targeted treatment of participants with high vascular inflammation taking IPE reduces vascular inflammation to a greater extent than standard of care treatment.
Summary of Results:
On 21st October 2025, the Sponsor and trial funder decided to end the IRIS-FAI trial early because too few patients were being recruited. Unfortunately, there was no additional funding to continue recruiting.
Even though all participating sites worked hard to find participants, it became clear that the study needed a specific type of participant that could not be found within the small number of sites and limited resources available. The decision to stop the study was based on these practical challenges, not on any safety or scientific concerns about the study medication.
Because of these issues, continuing the trial was not feasible, and, as a result, no study data will be shared.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0231
Date of REC Opinion
15 Aug 2024
REC opinion
Further Information Favourable Opinion