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.
Plain-language title generated from the registry record
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)
Key facts
- Where
- Blagoevgrad, Burgas, Gabrovo, Haskovo, Pazardzhik, Pleven, Plovdiv, Ruse, Sliven, Smolyan, Sofia, and Sofiya, BulgariaSee the 27 sites
- Phase
- Phase 3
Where in Bulgaria
- 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anthos Therapeutics, Inc.
- Trial code
- NCT05712200EU 2023-503224-66-00
- Record updated
- 13 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
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: 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.