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Bored Studies
RecruitingPhase 3

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)

Anthos Therapeutics, Inc. · with Novartis Pharmaceuticals · NCT05712200

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 65+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
2500
US sites recruiting
132
Study start
December 27, 2022
Record last updated
July 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Abelacimab; Placebo

Conditions: Atrial Fibrillation (AF)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Anthos Investigative Site 1040

    Birmingham, AL 35205

    Site contact: Ashley Gilmore · agilmore@uabmc.edu

  • Anthos Investigational site 9939

    Birmingham, AL 35233

    Site contact: Fadi Hage

  • Anthos Investigative Site 1041

    Mobile, AL 36608

    Site contact: Cheryl Flock · cflock@cbflockresearch.org

  • Anthos Investigative Site 1099

    Peoria, AZ 85381

    Site contact: Jocelyn Luque · jluque@suncitytrials.com

  • Anthos Investigative Site 9906

    Phoenix, AZ 85018

    Site contact: Nicole Ossino · nicole@eliteclinicalstudies.com

  • Anthos Investigative Site 9927

    Yuma, AZ 85365

    Site contact: Katie Welch · katie@yumaclinicaltrials.com

  • Anthos Investigative Site 9929

    Huntington Beach, CA 92648

    Site contact: Maria Trisa Palmares · tpalmares@nicresearch.com

  • Anthos Investigative Site 9959

    Imperial, CA 92251

    Site contact: Aaron Soto · aaron@biosolutionsresearch.com

  • Anthos Investigative Site 9921

    Lancaster, CA 93534

    Site contact: Aileen Doriguzzi · adoriguzzi@chemidox.com

  • Anthos Investigative Site 1078

    Loma Linda, CA 92357

    Site contact: Agnes Lee · agnes.lee2@va.gov

  • Anthos Investigative Site 1077

    Los Angeles, CA 90022

    Site contact: Yoltic Flores · flores@eastsideclinicalresearch.org

  • Anthos Investigational site 9821

    Orange, CA 92868

    Site contact: Karen Cruz · karen.cruz@damg.site

  • Anthos Investigative Site 1071

    San Dimas, CA 91773

    Site contact: Syeda Naqvi · snaqvi@nariresearch.com

  • Anthos Investigative Site 9938

    Santa Rosa, CA 95405

    Site contact: Julie Rosenberg · jrosenberg@northbayclinicalresearch.com

  • Anthos Investigative Site 9908

    South Gate, CA 90280

    Site contact: John Park · johnnie@charityhealth.net

  • Anthos Investigative Site 9907

    Vista, CA 92081

    Site contact: Mohammed Khalil · mohamed.khalil@bluecoastcardiology.com

  • Anthos Investigative Site 1095

    Aurora, CO 80045

    Site contact: Jennifer Golden · jennifer.golden@va.gov

  • Anthos Investigative Site 9922

    Golden, CO 80228

    Site contact: David Bailey · dbailey@chvpc.com

  • Anthos Investigative Site 1012

    Stamford, CT 06905

    Site contact: Stephanie Seredenko · sseredenko@cafconline.com

  • Anthos Investigative Site 9934

    Altamonte Springs, FL 32714

    Site contact: Megan Bodiford · mbodiford@heartorlando.com

  • Anthos Investigative Site 1013

    Boca Raton, FL 33486

    Site contact: Esthefany Jabbour · esthefany@fwdclinical.com

  • Anthos Investigational site 9810

    Bradenton, FL 34209

    Site contact: Mirabella Miranda · Mirabella.miranda@novaclinicalresearch.com

  • Anthos Investigational site 9818

    Clearwater, FL 33756

    Site contact: Delia Johnson · delia.johnson@baycare.org

  • Anthos Investigative Site 1025

    Clearwater, FL 33756

    Site contact: Carolyn Rembish · rembishc@cccheart.com

  • Anthos Investigative Site 1022

    Clearwater, FL 33777

    Site contact: Teresa Jones · jonest@cccheart.com

  • Anthos Investigative Site 1019

    Daytona Beach, FL 32114

    Site contact: Jennifer Langdon · jlangdon@daytonaheart.com

  • Anthos Investigative Site 9936

    Hialeah, FL 33012

    Site contact: Ana Fernandez · afernandez@evolutionresearchcenter.com

  • Anthos Investigative Site 9804

    Hollywood, FL 33020

    Site contact: Ariel Soffer

  • Anthos Investigative Site 1083

    Hollywood, FL 33024

    Site contact: Ana Gonzalez · agonzalez@innovativehealthmd.com

  • Anthos Investigational site 9808

    Jacksonville, FL 32209

    Site contact: Hayley Cheatwood · Hayley.cheatwood@ufhealth.org

  • Anthos Investigational site 9813

    Jacksonville, FL 32256

    Site contact: Leticia Robinson · lrobinson@cnshealthcare.com

  • Anthos Investigational site 9828

    Jacksonville, FL 32256

    Site contact: Christopher Chan · cchan@firstcoastcardio.com

  • Anthos Investigative Site 9904

    Lake Mary, FL 32746

    Site contact: Kiran Penta · kiran@aorcorp.com

  • Anthos Investigative Site 1093

    Lutz, FL 33558

    Site contact: Christian Kelbaugh · christian.kelbaugh@baycare.org

  • Anthos Investigative Site 9933

    Miami, FL 33145

    Site contact: Milene Garcia · mg.medoneclinicalresearch@outlook.com

  • Anthos Investigational site 9823

    Miami Lakes, FL 33014

    Site contact: Anabel Nuez · adelanuez@inpatientresearch.com

  • Anthos Investigative Site 9944

    Ocala, FL 34471

    Site contact: Arleana Brown · arleana.brown@morganmmc.com

  • Anthos Investigative Site 9940

    Ocala, FL 34474

    Site contact: Karen Perry · karen@ehsfamily.com

  • Anthis Investigational site 9811

    Pensacola, FL 32503

    Site contact: Jennifer Lehman · jennifer.lehmann@bhcpns.org

  • Anthos Investigational site9830

    Pensacola, FL 32504

    Site contact: Danielle struckel · danielle.struckel@ascension.org

  • Anthos Investigative Site 1026

    Safety Harbor, FL 34695

    Site contact: Laura Jenkins · jenkinsl@cccheart.com

  • Anthos Investigative Site 1002

    Saint Augustine, FL 32086

    Site contact: Keearah Galvao · keearah.galvao@eastcoastresearch.net

  • Anthos Investigative Site 1004

    Saint Augustine, FL 32086

    Site contact: Lucy Herter · lherter@encoredocs.com

  • Anthos Investigative Site 1044

    Tamarac, FL 33321

    Site contact: Enrique Fernandez · enrique.fernandez@careaccess.com

  • Anthos Investigative Site 1088

    Tamarac, FL 33321

    Site contact: Diego Sanchez · dsanchez@dhnrc.com

  • Anthos Investigative Site 9911

    The Villages, FL 32162

    Site contact: Stephanie Smith · stephanie.smith@globalaes.com

  • Anthos Investigative Site 1033

    Macon, GA 31201

    Site contact: Heather Maschenik · hmaschenik@gacri.com

  • Anthos Investigative Site 1003

    Suwanee, GA 30024

    Site contact: Charlotte Mall · charlotte@nscresearch.org

  • Anthos Investigative Site 9953

    Tucker, GA 30084

    Site contact: Andrew Mayer · amayer@ahsmed.com

  • Anthos Investigative Site 1030

    Park Ridge, IL 60068

    Site contact: Loria Awadallah · loria.awadallah@amr-clinical.com

  • Anthos Investigative Site 9932

    Rockford, IL 61107

    Site contact: Barbara Connors · barbara.l.connors@osfhealthcare.org

  • Anthos Investigative Site 9925

    Winfield, IL 60190

    Site contact: Ahad Ahmad · ahad.ahmad@accellacare.com

  • Anthos Investigative Site 9915

    Evansville, IN 47714

    Site contact: Abigail Hudson · abigail.hudson@globalaes.com

  • Anthos Investigative Site 1098

    Merrillville, IN 46410

    Site contact: Rehan Ahmed · rahmed@indianaclinicalresearch.com

  • Anthos Investigative Site 9956

    West Des Moines, IA 50266

    Site contact: Ahymad Lee · alee@innovoresearch.com

  • Anthos Investigative Site 9958

    Hutchinson, KS 67502

    Site contact: Amy Martens · amartens@innovoresearch.com

  • Anthos Investigative Site 1016

    Wichita, KS 67207

    Site contact: Erina Kulitek · Erina.Kutilek@amr-clinical.com

  • Anthos Investigational site 9968

    Eunice, LA 70535

    Site contact: Rechell Barzas · rechell.barzas@careaccess.com

  • Anthos Investigative Site 1043

    Shreveport, LA 71103

    Site contact: Iris Cahn · gcahn.cvsolutions@gmail.com

  • Anthos Investigational site 9803

    West Monroe, LA 71291

    Site contact: Nina Parrot · nparrott76@gmail.com

+ 72 more on the official record.

Study contacts (from the official record)

  • Anthos Therapeutics a Novartis Company · 1-888-669-6682 · novartis.email@novartis.com