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LILAC-TIMI 76 Study for Atrial Fibrillation

This study is looking at a medicine called abelacimab for people with atrial fibrillation (an irregular heartbeat) who are considered unsuitable for standard blood thinners. We want to see if abelacimab can reduce the risk of ischemic stroke (a type of stroke caused by a blood clot) or systemic embolism (a blood clot that travels through the body). You might be able to join if you are 65 or older, have atrial fibrillation, and your doctor believes you shouldn't take typical blood thinners. The study will also check for any serious bleeding side effects. We plan to enroll about 2500 participants, but the current status of the study is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive either abelacimab or a placebo (an inactive substance) once a month. The study is double-blind, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
You would go through a screening period of up to 60 days, followed by a treatment period where you receive monthly injections. There will be a final visit at the end of treatment, and some participants may have the option to continue receiving abelacimab.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 30 months to track the occurrence of stroke, systemic embolism, or serious bleeding events. After the main treatment period, there will be a 30-day follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05712200

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-TIMI 76)

Recruiting
PHASE3Ages 65+InterventionalTreatment
Anthos Therapeutics, Inc.
~2,500 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:AbelacimabPlacebo

At a glance

Recruiting sites
645 of 789 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
Measured over Up to 30 months
+1 more outcome measured

Conditions

Atrial Fibrillation (AF)

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NCT05712200

Where you'd take part

This study runs at 789 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Anthis Investigational site 9811

    Pensacola, Floridastudy coordinator listed

    Recruiting

  • Anthos Investigational site 9801

    Sewell, New Jerseystudy coordinator listed

    Recruiting

  • Anthos Investigational site 9803

    West Monroe, Louisianastudy coordinator listed

    Recruiting

  • Anthos Investigational Site 9807

    Elmer, New Jerseystudy coordinator listed

    Recruiting

  • Anthos Investigational site 9808

    Jacksonville, Floridastudy coordinator listed

    Recruiting

  • Anthos Investigational site 9810

    Bradenton, Floridastudy coordinator listed

    Recruiting

  • Anthos Investigational site 9812

    Fall River, Massachusettsstudy coordinator listed

    Recruiting

  • Anthos Investigational site 9813

    Jacksonville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Anthos Therapeutics a Novartis Company
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

Patient is able to understand and has provided written informed consent 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
Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls
Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study

Exclusion

AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
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 (surgical or invasive) during the course of the study
Patients on dialysis at screening or who are planned to start dialysis within 6 months

What this trial measures

  • Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)Up to 30 months

    Undetermined strokes will be counted as ischemic strokes

  • Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleedingUp to 30 months