At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Abelacimab (biological), Placebo (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Abelacimab — biological: Abelacimab provided as liquid in vial (150 mg/mL) · Placebo — drug: Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called LILAC-TIMI 76 and funded by Anthos Therapeutics, Inc., is testing how well and how safely a medicine called abelacimab works in people with atrial fibrillation (an irregular heartbeat) who are at high risk and cannot take, or do not want to take, blood-thinning tablets. It focuses on people who are unsuitable for standard oral anticoagulation (blood-thinning) medicines.
Who can take part
- You can give written informed consent and understand the trial
- You have been diagnosed with atrial fibrillation or atrial flutter (shown on a heart tracing or monitor)
- You are aged 65-74 with a CHA2DS2-VASc score of 4 or more (a score measuring stroke risk), or aged 75 or over with a score of 3 or more
- Your doctor has decided, before the study, that blood-thinning tablets are not suitable for you or you are unwilling to take them
- You have at least one bleeding risk factor, such as severe kidney problems, planned daily antiplatelet medicine, past bleeding in a critical area, regular use of anti-inflammatory painkillers (NSAIDs), frailty or frequent falls
- Your doctor has decided you are unsuitable for a left atrial appendage closure device (a small device fitted in the heart), it is not available, or you are unwilling to have the procedure
Who may not be able to
- Your atrial fibrillation is caused by a short-term treatable problem, such as recent heart surgery, a blood clot in the lungs, an overactive thyroid, or alcohol use
- You took blood-thinning tablets (such as warfarin, dabigatran, rivaroxaban, apixaban or edoxaban) in the 60 days before joining, or your atrial fibrillation was newly diagnosed in that time
- You had bleeding in the brain or eye in the 3 months before screening, or have ever had a brain bleed without blood-thinning treatment
- You had a stroke in the 14 days before joining or a mini-stroke (TIA) in the 3 days before joining
- You have a mechanical heart valve or heart valve disease expected to need a mechanical valve replacement during the study
- You are on dialysis or due to start dialysis within 6 months
- Other criteria in the study plan may also apply
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 65 Years and over
- Who
- All
- Number of participants
- 2,500
- Started
- 2022-12-27
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation (af)
- • Phase3 - 2,500 participants
- • A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy
Who can take part?
- • Ages 65 Years and over
- • Diagnosed with atrial fibrillation (af)
Where?
- • Bollington - Anthos Investigational site 1327
- • Blackpool - Anthos Investigational site 1329
- • Brierley Hill - Anthos Investigational site 1328
- • Corby - Anthos Investigative Site 1303
- • +25 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.
More detail
Patients enrolled in the study are randomized in a 1:1 ratio to receive abelacimab 150 mg SC or matching placebo once monthly. The study is comprised of 3 periods: 1) screening period of up to 60 days, 2) an event-driven, double-blind treatment period (abelacimab 150 mg SC or matching placebo) completed after at least 111 patients have experienced an adjudicated primary endpoint event, and 3) EoT visit in core part followed by either (i) a 30-day follow-up period (EoS for core part) OR (ii) an optional OLE beginning at the EoT visit for eligible patients to receive open-label abelacimab treatment. The optional extension will only be offered to patients following regulatory and ethics approval in participating countries.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 65 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patient is able to understand and has provided written agreement to take part to participate in the trial
- ✓Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
- ✓Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
Who cannot take part
- ✗AF due to an ongoing acute reversible cause (e.g., heart surgery, lung embolism (PE), untreated...
- ✗Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of...
- ✗Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
- ✗Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention...
- ✗Patients on dialysis at screening or who are planned to start dialysis within 6 months
See the full criteria
Where Is This Study? (29 UK sites)
Anthos Investigational site 1327
Bollington SK105JH, United Kingdom
Anthos Investigational site 1329
Blackpool FY3 8NR, United Kingdom
Anthos Investigational site 1328
Brierley Hill DY5 1RU, United Kingdom
Anthos Investigative Site 1303
Corby NN17 2UR, United Kingdom
Anthos Investigative Site 1313
Glasgow G20 0XA, United Kingdom
Anthos Investigative Site 1320
Glasgow G51 4TF, United Kingdom
Anthos Investigative Site 1315
Hayle TR27 5DT, United Kingdom
Anthos Investigative Site 1311
High Wycombe HP11 2TT, United Kingdom
Anthos Investigative Site 1301
Isleworth TW7 6AF, United Kingdom
Anthos Investigative Site 1316
Kings Lynn PE30 4ET, United Kingdom
Anthos Investigative Site 1324
Lancaster LA1 4ZP, United Kingdom
Anthos Investigative Site 1322
Larbert FK5 4WR, United Kingdom
Anthos Investigative Site 1309
Leeds LS1 3EX, United Kingdom
Anthos Investigative Site 1325
Liverpool L14 3PE, United Kingdom
Anthos Investigative Site 1314
London IG1 4HP, United Kingdom
Anthos Investigative Site 1319
London NW1 5DH, United Kingdom
Anthos Investigative Site 1326
London NW10 2PT, United Kingdom
Anthos Investigative Site 1308
London SW3 6NP, United Kingdom
Anthos Investigative Site 1323
Luton LU4 0DZ, United Kingdom
Anthos Investigative Site 1312
Manchester M27 8FF, United Kingdom
Anthos Investigative Site 1307
Newcastle upon Tyne NE7 7DN, United Kingdom
Anthos Investigative Site 1318
Norwich NR2 2TJ, United Kingdom
Anthos Investigational site 1330
Oxford OX3 9JA, United Kingdom
Anthos Investigative Site 1305
Peterborough PE3 9GZ, United Kingdom
Anthos Investigative Site 1321
Romford RM7 0AG, United Kingdom
Anthos Investigative Site 1302
Stevenage SG1 4AB, United Kingdom
Anthos Investigative Site 1310
Stockton-on-Tees TS19 8PE, United Kingdom
Anthos Investigative Site 1317
Stoke-on-Trent ST4 6QG, United Kingdom
Anthos Investigative Site 1306
Taunton TA1 5DA, United Kingdom
How to Get in Touch
Anthos Therapeutics a Novartis Company
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