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Taking people in BulgariaPhase 3

Tests abelacimab against placebo in atrial fibrillation patients unable to take oral blood thinners

Tests abelacimab against placebo in older adults with atrial fibrillation who cannot take blood thinners.

Key facts

Who runs it
Anthos Therapeutics, Inc.
Where
Blagoevgrad, Burgas, Gabrovo, Haskovo, Pazardzhik, Pleven, Plovdiv, Ruse, Sliven, Smolyan, Sofia, and Sofiya, BulgariaSee the 27 sitesAlso in 34 other countries, 746 sites
Registry title
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)
Status
Recruiting
Phase
Phase 3
People taking part
2,500 people, planned
Started
27 Dec 2022
Expected to end
30 Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Abelacimab
  • Placebo
Record updated
13 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for older adults with atrial fibrillation or atrial flutter and a high stroke risk. Their doctor must have judged them unsuitable for blood-thinning tablets, or they refuse them.

Age
65 years or older. Ages 65-74 need a CHA2DS2VASc score of 4 or more. Age 75 and over needs a score of 3 or more.
Sex
All sexes can join.
Disease stage
Atrial fibrillation or atrial flutter shown on an ECG or monitor recording. At least 1 bleeding risk factor is needed, such as severe kidney problems, daily antiplatelet medicine, past bleeding from a critical area, frailty or multiple falls.
Earlier treatment
Unsuitable for oral anticoagulation, or unwilling to take it. Also unsuitable for a left atrial appendage closure device, or unwilling to have one, or no approved device is available. These decisions were made before and independent of the study. No vitamin K antagonist or direct oral anticoagulant in the last 60 days.

Main reasons for not taking part

  • AF caused by a short-term reversible cause, such as cardiac surgery or untreated hyperthyroidism
  • Intracranial or intraocular bleed in the last 3 months, or any past spontaneous brain bleed without blood-thinning treatment
  • Stroke in the last 14 days or TIA in the last 3 days
  • Mechanical heart valve, or valve disease likely to need mechanical valve replacement
  • On dialysis, or dialysis planned within 6 months

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
  • 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; Other protocol defined Inclusion/Exclusion criteria may apply

Where in Bulgaria

Also in 34 other countries, 746 sites

  • Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls ADBlagoevgrad, BulgariaTaking people
  • Universitetska Mnogoprofilna bolnica za aktivno lechenie Deva Maria EOODBurgas, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" ADGabrovo, BulgariaTaking people
  • Diagnostics And Consultancy Center Sveti Georgi EOODHaskovo, BulgariaTaking people
  • Multidisciplinary Hospital For Active Treatment Haskovo ADHaskovo, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment Pazardzik ADPazardzhik, BulgariaTaking people
  • Medical Center Medconsult Pleven OODPleven, BulgariaTaking people
  • Multi-profile Hospital for Active Treatment Heart and Brain EADPleven, BulgariaTaking people
  • MBAL Sveta Karidad EADPlovdiv, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment Medical Complex Sveti Ivan Rilski EOODPlovdiv, BulgariaTaking people
  • University Multiprofile Hospital For Active Treatment Saint Georgi EADPlovdiv, BulgariaTaking people
  • University Multiprophy Hospital For Active Treatment - Plovdiv ADPlovdiv, BulgariaTaking people
  • Specialized Hospital For Active Cardiology Treatment Medica Kor EADRuse, BulgariaTaking people
  • Group Practice For Specialized Medical Care Inakor Ltd.Sliven, BulgariaTaking people
  • MBAL Dr. Ivan Seliminski Sliven ADSliven, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov ADSmolyan, BulgariaTaking people
  • Alexandrovska University HospitalSofia, BulgariaTaking people
  • Diagnostic Consultative Centre Ascendent OODSofia, BulgariaTaking people
  • Medical center NeoGeneX Ltd.Sofia, BulgariaTaking people
  • Medical centre Kardiohelp EOODSofia, BulgariaTaking people
  • Multiprofile Hospital for Active Treatment "Knyaginya Klementina" - Sofia EADSofia, BulgariaTaking people
  • Tokuda HospitalSofia, BulgariaTaking people
  • Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EADSofia, BulgariaTaking people
  • University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EADSofia, BulgariaTaking people
  • Military Medical AcademySofiya, BulgariaTaking people
  • University Hospital St. AnnaSofiya, BulgariaTaking people
  • University Multiprofile Hospital For Active Treatment And Emergency Medicine N I PirogovSofiya, BulgariaTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Abelacimab (MAA868)Treatment being tested

    Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

    Treatment: Abelacimab

  • PlaceboPlacebo, for comparison

    Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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-TIMI 76)
Plain-language title
Tests abelacimab against placebo in atrial fibrillation patients unable to take oral blood thinnersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 July 2026