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
- Ancona, Bergamo, Brescia, Cagliari, Caserta, Faenza, Florence, Lecco, Milan, Naples, Palermo, Pisa, Rimini, Rivoli, Rome, Saronno, Sesto San Giovanni, Turin, and Varese, ItalySee the 24 sites
- Phase
- Phase 3
Where in Italy
- I.N.R.C.A. Istituto Nazionale di Riposo E Cura Per Gli AnzianiAncona, ItalyTaking people
- Azienda Ospedaliera Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Socio Sanitaria Locale N. 8 Di CagliariCagliari, ItalyTaking people
- Azienda Ospedaliera Sant'Anna E San Sebastiano Di CasertaCaserta, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaFaenza, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Alessandro Manzoni HospitalLecco, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Fondazione Toscana Gabriele MonasterioPisa, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
- Azienda Sanitaria Locale TO3Rivoli, ItalyTaking people
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- San Camillo Forlanini HospitalRome, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Della Valle OlonaSaronno, ItalyTaking people
- Azienda Socio-Sanitaria Territoriale Nord MilanoSesto San Giovanni, ItalyTaking people
- Multimedica S.p.A.Sesto San Giovanni, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking 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.