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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)

RecruitingPhase 3

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)

Who can join

Ages 65 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Anthos Therapeutics, Inc. · Participants: 2,500 · Started: Dec 27, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05712200

Locations in the U.S.

AlabamaAnthos Investigational site 9939, Birmingham
Anthos Investigative Site 1040, Birmingham
Anthos Investigative Site 9947, Birmingham (Not yet recruiting)
Anthos Investigative Site 1041, Mobile
ArizonaAnthos Investigative Site 1099, Peoria
Anthos Investigative Site 9906, Phoenix
Anthos Investigative Site 9927, Yuma
CaliforniaAnthos Investigative Site 9929, Huntington Beach
Anthos Investigative Site 9959, Imperial
Anthos Investigative Site 9921, Lancaster
Anthos Investigative Site 1078, Loma Linda
Anthos Investigative Site 1077, Los Angeles
Anthos Investigational site 9821, Orange
Anthos Investigative Site 1071, San Dimas
Anthos Investigative Site 9938, Santa Rosa
Anthos Investigative Site 9908, South Gate
Anthos Investigative Site 9907, Vista
ColoradoAnthos Investigative Site 1095, Aurora
Anthos Investigative Site 9922, Golden
ConnecticutAnthos Investigative Site 1012, Stamford
FloridaAnthos Investigative Site 9934, Altamonte Springs
Anthos Investigative Site 1013, Boca Raton
Anthos Investigational site 9810, Bradenton
Anthos Investigational site 9818, Clearwater
Anthos Investigative Site 1022, Clearwater
Anthos Investigative Site 1025, Clearwater
Anthos Investigative Site 1019, Daytona Beach
Anthos Investigative Site 9936, Hialeah
Anthos Investigative Site 1083, Hollywood
Anthos Investigative Site 9804, Hollywood
Anthos Investigational site 9808, Jacksonville
Anthos Investigational site 9813, Jacksonville
Anthos Investigational site 9828, Jacksonville
Anthos Investigative Site 9904, Lake Mary
Anthos Investigative Site 1093, Lutz
Anthos Investigative Site 9933, Miami
Anthos Investigational site 9823, Miami Lakes
Anthos Investigative Site 9940, Ocala
Anthos Investigative Site 9944, Ocala
Anthis Investigational site 9811, Pensacola
Anthos Investigational site9830, Pensacola
Anthos Investigative Site 1026, Safety Harbor
Anthos Investigative Site 1002, Saint Augustine
Anthos Investigative Site 1004, Saint Augustine
Anthos Investigative Site 1044, Tamarac
Anthos Investigative Site 1088, Tamarac
Anthos Investigative Site 9911, The Villages
GeorgiaAnthos Investigative Site 1033, Macon
Anthos Investigative Site 1003, Suwanee
Anthos Investigative Site 9953, Tucker
IllinoisAnthos Investigative Site 1030, Park Ridge
Anthos Investigative Site 9932, Rockford
Anthos Investigative Site 9925, Winfield
IndianaAnthos Investigative Site 9915, Evansville
Anthos Investigative Site 1098, Merrillville
IowaAnthos Investigative Site 9956, West Des Moines
KansasAnthos Investigative Site 9958, Hutchinson
Anthos Investigative Site 1016, Wichita
LouisianaAnthos Investigational site 9968, Eunice
Anthos Investigative Site 1043, Shreveport
Anthos Investigational site 9803, West Monroe
MaineAnthos Investigative Site 1054, Bangor
MarylandAnthos Investigational site 9961, Baltimore
Anthos Investigational site 9965, Baltimore
Anthos Investigative Site 1039, Baltimore
Anthos Investigative Site 9957, Baltimore
Anthos Investigative Site 1023, Lanham
Anthos Investigational site 9962, Rockville
Anthos Investigational site 9969, Salisbury
MassachusettsAnthos Investigative Site 9918, Boston
Anthos Investigational site 9812, Fall River
MichiganAnthos Investigational site 9819, Lansing
Anthos Investigative Site 1021, Lansing
Anthos Investigative Site 9946, Petoskey
Anthos Investigative Site 1059, Southgate
MissouriAnthos Investigative Site 1080, Kansa City
Anthos Investigative Site 9948, Kansas City
Anthos Investigational site 9825, St Louis
Anthos Investigational site 9966, St Louis
NevadaAnthos Investigative Site 9914, Las Vegas
New JerseyAnthos Investigational Site 9807, Elmer
Anthos Investigational site 9801, Sewell
Anthos Investigational site 9963, Somerset
New YorkAnthos Investigative Site 9931, Albany
Anthos Investigative Site 9905, Brooklyn
Anthos Investigational site 9829, Hauppauge
Anthos Investigative Site 1037, Rosedale
Anthos Investigative Site 9935, Stony Brook
Anthos Investigative Site 9920, Valhalla
North CarolinaAnthos Investigative Site 1005, Charlotte
Anthos Investigative Site 9912, Durham
Anthos Investigative Site 9950, Pinehurst
Anthos Investigative Site 9951, Statesville
Anthos Investigative Site 9952, Wilmington
OhioAnthos Investigative Site 9902, Beavercreek
Anthos Investigative Site 9945, Dayton
OklahomaAnthos Investigative Site 9917, Oklahoma City
OregonAnthos Investigative Site 1075, Portland
PennsylvaniaAnthos Investigative Site 1087, Horsham
South CarolinaAnthos Investigational site 9814, Fort Mill
TennesseeAnthos Investigational site 9954, Chattanooga
Anthos Investigative Site 9941, Jefferson City
Anthos Investigative Site 1056, Memphis
TexasAnthos Investigative Site 9928, Allen
Anthos Investigative Site 9913, Beaumont
Anthos Investigational site 9967, Bryan
Anthos Investigative Site 9942, Dallas
Anthos Investigative Site 9943, Dallas
Anthos Investigative Site 1091, El Paso
Anthos Investigative Site 9930, Greenville
Anthos Investigative Site 1064, Houston
Anthos Investigative Site 1068, Houston
Anthos Investigative Site 1097, Houston
Anthos Investigative Site 9903, Houston
Anthos Investigational site 9833, Humble
Anthos Investigative Site 1063, McAllen
Anthos Investigative Site 1079, McKinney
Anthos Investigative Site 1096, McKinney
Anthos Investigative Site 1024, Odessa
Anthos Investigative Site 1085, Port Arthur
Anthos Investigative Site 9923, Sherman
Anthos Investigative Site 9916, Tyler
Anthos Investigative Site 9910, Victoria
Anthos Investigative Site 1060, Waco
Anthos Investigative Site 9909, Webster
Anthos Investigative Site 1092, Wylie
VirginiaAnthos Investigative Site 1018, Falls Church
Anthos Investigational site 9817, Fredericksburg
Anthos Investigative Site 1009, Roanoke
Anthos Investigative Site 9949, Vienna
WashingtonAnthos Investigational site 9826, Puyallup
Anthos Investigative Site 9926, Redmond
Anthos Investigative Site 1073, Tacoma

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.