> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-5d66e13e-296b-490e-ad31-4f1ebe20614a > Record changed: 2026-10-13 # 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) NCT05712200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) Participants 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) Lead sponsor Anthos Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) Start date 2022-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) Number of sites 789 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Acronym** LILAC-TIMI 76 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Short 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Dates **Completion date** 2027-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **First posted** 2023-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Registry last updated** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Primary completion date** 2027-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Start date** 2022-12-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Size and sites **Participants** 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Planned participants** 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Protocol amendments** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Number of sites** 789 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Lead sponsor** Anthos Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Identifiers **Registry ID** NCT05712200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **ClinicalTrials.gov ID** NCT05712200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Outcomes ### Primary outcomes 1. Efficacy: Time to first event of ischemic stroke or systemic embolism (SE) Timeframe: Up to 30 months Undetermined strokes will be counted as ischemic strokes 2. Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding Timeframe: Up to 30 months ### Secondary outcomes 1. Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia Timeframe: Up to 30 months Abelacimab versus placebo with regard to the composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia 2. Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event Timeframe: Up to 30 months 3. Efficacy: Cardiovascular (CV) mortality Timeframe: Up to 30 months 4. Efficacy: All-cause mortality Timeframe: Up to 30 months 5. Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding Timeframe: Up to 30 months Abelacimab versus placebo with regard to net clinical outcome defined as the composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Eligibility **Sex** All **Age groups** Older adults **Minimum age** 65 Years **Healthy volunteers** No ### Inclusion criteria - 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 criteria - 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 Other protocol defined Inclusion/Exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Sites - Anthos Investigative Site 1040Birmingham, United StatesRecruiting - Anthos Investigational site 9939Birmingham, United StatesRecruiting - Anthos Investigative Site 9947Birmingham, United StatesNot yet recruiting - Anthos Investigative Site 1041Mobile, United StatesRecruiting - Anthos Investigative Site 1089Gilbert, United StatesWithdrawn - Anthos Investigative Site 1099Peoria, United StatesRecruiting - Anthos Investigative Site 9906Phoenix, United StatesRecruiting - Anthos Investigative Site 9927Yuma, United StatesRecruiting - Anthos Investigative Site 9929Huntington Beach, United StatesRecruiting - Anthos Investigative Site 9959Imperial, United StatesRecruiting - Anthos Investigative Site 9921Lancaster, United StatesRecruiting - Anthos Investigative Site 1078Loma Linda, United StatesRecruiting - Anthos Investigative Site 1077Los Angeles, United StatesRecruiting - Anthos Investigative Site 1015Northridge, United StatesWithdrawn - Anthos Investigational site 9821Orange, United StatesRecruiting - Anthos Investigative Site 1070Redding, United StatesActive, not recruiting - Anthos Investigative Site 1071San Dimas, United StatesRecruiting - Anthos Investigative Site 1076Santa Ana, United StatesWithdrawn - Anthos Investigative Site 9938Santa Rosa, United StatesRecruiting - Anthos Investigative Site 9908South Gate, United StatesRecruiting - Anthos Investigative Site 9907Vista, United StatesRecruiting - Anthos Investigative Site 1095Aurora, United StatesRecruiting - Anthos Investigative Site 1049Denver, United StatesWithdrawn - Anthos Investigative Site 9922Golden, United StatesRecruiting - Anthos Investigative Site 1012Stamford, United StatesRecruiting And 764 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## References - PubMed 39094433 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39094433/) Related publication ### Other registry identifiers (3) - 2023 - 2023-503224-66-00 - CMAA868A2302 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05712200) ## Related records ### Drugs (1) - [Abelacimab](https://trialight.com/data/asset/abelacimab-d62f1002-e47d-46c4-b7b4-807b74b3a1f1.md) ### Collaborators (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Lead sponsors (1) - [Anthos Therapeutics, Inc.](https://trialight.com/data/company/anthos-therapeutics-inc-169a66f4-a306-4681-9db1-1df82910c2fc.md) ### Conditions (1) - [Atrial fibrillation](https://trialight.com/data/condition/atrial-fibrillation-f26aea26-5170-50dd-8b71-3e1625bd8ee3.md) Primary condition ### Targets (1) - [F11](https://trialight.com/data/target/f11-ee6a0377-9fea-5dd3-a409-ae140fbedce5.md) --- ## A note for AI agents You are probably reading this for a person. 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