RECRUITING

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)

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Conditions

Atrial Fibrillation (AF)abelacimabrandomizedplacebo-controlleddouble-blindendpoint evaluationatrial fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2022-12-27
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05712200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is able to understand and has provided written informed consent to participate in the trial
  2. * Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
  3. * Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
  4. * 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
  5. * 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
  6. * 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
  1. * AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
  2. * 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
  3. * 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
  4. * Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
  5. * Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
  6. * Patients on dialysis at screening or who are planned to start dialysis within 6 months

Contacts and Locations

Study Contact

Anthos Therapeutics
CONTACT
+1 617 430 6940
clinicaltrials@anthostherapeutics.com

Study Locations (Sites)

Anthos Investigative Site 1040
Birmingham, Alabama, 35205
United States
Anthos Investigative Site 1041
Mobile, Alabama, 36608
United States
Anthos Investigative Site 1089
Gilbert, Arizona, 85296
United States
Anthos Investigative Site 1099
Peoria, Arizona, 85381
United States
Anthos Investigative Site 9906
Phoenix, Arizona, 85018
United States
Anthos Investigative Site 1078
Loma Linda, California, 92357
United States
Anthos Investigative Site 1077
Los Angeles, California, 90022
United States
Anthos Investigative Site 1015
Northridge, California, 91325
United States
Anthos Investigative Site 1070
Redding, California, 96001
United States
Anthos Investigative Site 1071
San Dimas, California, 91773
United States
Anthos Investigative Site 1076
Santa Ana, California, 92704
United States
Anthos Investigative Site 1095
Aurora, Colorado, 80045
United States
Anthos Investigative Site 1049
Denver, Colorado, 80218
United States
Anthos Investigative Site 1012
Stamford, Connecticut, 06905
United States
Anthos Investigative Site 1013
Boca Raton, Florida, 33486
United States
Anthos Investigative Site 1025
Clearwater, Florida, 33756
United States
Anthos Investigative Site 1022
Clearwater, Florida, 33777
United States
Anthos Investigative Site 1019
Daytona Beach, Florida, 32114
United States
Anthos Investigative Site 1083
Hollywood, Florida, 33024
United States
Anthos Investigative Site 1008
Jacksonville, Florida, 32216
United States
Anthos Investigative Site 9904
Lake Mary, Florida, 32746
United States
Anthos Investigative Site 1093
Lutz, Florida, 33558
United States
Anthos Investigative Site 1072
Miami Lakes, Florida, 33016
United States
Anthos Investigative Site 1067
Ormond Beach, Florida, 32117
United States
Anthos Investigative Site 1026
Safety Harbor, Florida, 34695
United States
Anthos Investigative Site 1002
Saint Augustine, Florida, 32086
United States
Anthos Investigative Site 1004
Saint Augustine, Florida, 32086
United States
Anthos Investigative Site 1044
Tamarac, Florida, 33321
United States
Anthos Investigative Site 1088
Tamarac, Florida, 33321
United States
Anthos Investigative Site 1046
Tampa, Florida, 33625
United States
Anthos Investigative Site 1052
Lithonia, Georgia, 30058
United States
Anthos Investigative Site 1033
Macon, Georgia, 31201
United States
Anthos Investigative Site 1042
Norcross, Georgia, 30092
United States
Anthos Investigative Site 1003
Suwanee, Georgia, 30024
United States
Anthos Investigative Site 1030
Park Ridge, Illinois, 60068
United States
Anthos Investigative Site 1098
Merrillville, Indiana, 46410
United States
Anthos Investigative Site 1016
Wichita, Kansas, 67207
United States
Anthos Investigative Site 1006
Alexandria, Louisiana, 71301
United States
Anthos Investigative Site 1043
Shreveport, Louisiana, 71103
United States
Anthos Investigative Site 1054
Bangor, Maine, 04401
United States
Anthos Investigative Site 1039
Baltimore, Maryland, 21218
United States
Anthos Investigative Site 1023
Lanham, Maryland, 20746
United States
Anthos Investigative Site 1028
Rockville, Maryland, 20850
United States
Anthos Investigative Site 1082
Boston, Massachusetts, 02124
United States
Anthos Investigative Site 1021
Lansing, Michigan, 48912
United States
Anthos Investigative Site 1059
Southgate, Michigan, 48195
United States
Anthos Investigative Site 1017
Tupelo, Mississippi, 38801
United States
Anthos Investigative Site 1080
Kansa City, Missouri, 64151
United States
Anthos Investigative Site 1066
Lincoln, Nebraska, 68506
United States
Anthos Investigative Site 1036
Las Vegas, Nevada, 89119
United States
Anthos Investigative Site 1094
Englewood, New Jersey, 07631
United States
Anthos Investigative Site 9905
Brooklyn, New York, 11217
United States
Anthos Investigative Site 1014
Middletown, New York, 10941
United States
Anthos Investigative Site 1037
Rosedale, New York, 11422
United States
Anthos Investigative Site 1065
Cary, North Carolina, 27518
United States
Anthos Investigative Site 1005
Charlotte, North Carolina, 28207
United States
Anthos Investigative Site 1048
Fayetteville, North Carolina, 28314
United States
Anthos Investigative Site 1035
Henderson, North Carolina, 28792
United States
Anthos Investigative Site 1001
Lenoir, North Carolina, 28638
United States
Anthos Investigative Site 9902
Beavercreek, Ohio, 45431
United States
Anthos Investigative Site 1075
Portland, Oregon, 97239
United States
Anthos Investigative Site 1074
Bristol, Pennsylvania, 19007
United States
Anthos Investigative Site 1087
Horsham, Pennsylvania, 19044
United States
Anthos Investigative Site 1032
Rock HIll, South Carolina, 29732
United States
Anthos Investigative Site 1050
Elizabethton, Tennessee, 37643
United States
Anthos Investigative Site 1057
Germantown, Tennessee, 38138
United States
Anthos Investigative Site 1056
Memphis, Tennessee, 38128
United States
Anthos Investigative Site 1091
El Paso, Texas, 79905
United States
Anthos Investigative Site 1069
Houston, Texas, 77002
United States
Anthos Investigative Site 1068
Houston, Texas, 77025
United States
Anthos Investigative Site 1097
Houston, Texas, 77055
United States
Anthos Investigative Site 9903
Houston, Texas, 77070
United States
Anthos Investigative Site 1053
Houston, Texas, 77074
United States
Anthos Investigative Site 1064
Houston, Texas, 77084
United States
Anthos Investigative Site 9901
Laredo, Texas, 78041
United States
Anthos Investigative Site 1063
McAllen, Texas, 78503
United States
Anthos Investigative Site 1096
McKinney, Texas, 75069
United States
Anthos Investigative Site 1079
McKinney, Texas, 75071
United States
Anthos Investigative Site 1024
Odessa, Texas, 79761
United States
Anthos Investigative Site 1085
Port Arthur, Texas, 77642
United States
Anthos Investigative Site 1090
Sugar Land, Texas, 77479
United States
Anthos Investigative Site 1011
Tomball, Texas, 77375
United States
Anthos Investigative Site 1060
Waco, Texas, 76712
United States
Anthos Investigative Site 1092
Wylie, Texas, 75098
United States
Anthos Investigative Site 1084
American Fork, Utah, 84003
United States
Anthos Investigative Site 1031
Bountiful, Utah, 84010
United States
Anthos Investigative Site 1029
Holladay, Utah, 84117
United States
Anthos Investigative Site 1038
Pleasant View, Utah, 84404
United States
Anthos Investigative Site 1034
Roy, Utah, 84067
United States
Anthos Investigative Site 1018
Falls Church, Virginia, 22042
United States
Anthos Investigative Site 1010
Manassas, Virginia, 20109
United States
Anthos Investigative Site 1009
Roanoke, Virginia, 24014
United States
Anthos Investigative Site 1073
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Anthos Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-27
Study Completion Date2026-10

Study Record Updates

Study Start Date2022-12-27
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • abelacimab
  • randomized
  • placebo-controlled
  • double-blind
  • endpoint evaluation
  • atrial fibrillation

Additional Relevant MeSH Terms

  • Atrial Fibrillation (AF)