LILAC
Research type
Research Study
Full title
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaLuate the effIcacy and safety of abeLacimab in high-risk patients with Atrial fibrillation who have been deemed unsuitable for oral antiCoagulation (LILAC)
IRAS ID
1007115
Contact name
Nikhil Mehta
Contact email
Sponsor organisation
Anthos Therapeutics
Clinicaltrials.gov Identifier
Research summary
Atrial fibrillation (AF) is a heart condition that causes the heart to beat irregularly. It is the most common heart rhythm disturbance and affects more than 1 million people in the UK. People with AF are at risk for stroke, a serious, life-threatening condition that occurs when the blood supply is cut off to part of the brain.
‘Blood thinning’ medications are often given to patients with AF to prevent blood clots from forming. Most patients with AF require lifelong blood thinning medication; however, existing blood thinners also increase the risk of bleeding. In some cases, patients cannot be given blood thinners to prevent stroke because they have an elevated risk of bleeding or because they have bled in the past.
Abelacimab is an experimental blood thinner that works differently than the usual blood thinners. Because it works differently, abelacimab might be able to prevent strokes without increasing the risk of serious bleeding.
This trial will find out about the safety and effectiveness of abelacimab taken once a month in patients with AF who do not take blood thinners because they can’t take them or don’t want to take them.
Patients taking part in this trial have a 50-50 chance of getting abelacimab or placebo. The length of treatment might be a year and a half but depends on when the participant enters the trial and how the trial is progressing. The whole trial could take about 2 and a half years. About 1900 patients will take part in this trial.
At the study visits, participants will be checked for health issues and side effects. Participants will also have a physical examination, their blood pressure and heart rate will be measured, and a small blood sample will be taken. Participants will also be asked to complete questionnaires about their health.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0324
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion