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)

Recruiting · NCT05712200 · Interventional (participants receive a specific treatment) · Lead sponsor: Anthos Therapeutics, Inc.

View the official record on ClinicalTrials.gov →

Atrial fibrillation

Interventions studied

AbelacimabPlacebo

What this trial 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.

Who can take part

Age range

65 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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
ther protocol defined Inclusion/Exclusion criteria may apply

Where it is running

60 locations listed across 33 US states.

Anthos Investigative Site 1040 - Birmingham, Alabama, United States
Anthos Investigational site 9939 - Birmingham, Alabama, United States
Anthos Investigative Site 9947 - Birmingham, Alabama, United States
Anthos Investigative Site 1041 - Mobile, Alabama, United States
Anthos Investigative Site 1089 - Gilbert, Arizona, United States
Anthos Investigative Site 1099 - Peoria, Arizona, United States
Anthos Investigative Site 9906 - Phoenix, Arizona, United States
Anthos Investigative Site 9927 - Yuma, Arizona, United States
Anthos Investigative Site 9929 - Huntington Beach, California, United States
Anthos Investigative Site 9959 - Imperial, California, United States
Anthos Investigative Site 9921 - Lancaster, California, United States
Anthos Investigative Site 1078 - Loma Linda, California, United States
Anthos Investigative Site 1077 - Los Angeles, California, United States
Anthos Investigative Site 1015 - Northridge, California, United States
Anthos Investigational site 9821 - Orange, California, United States
Anthos Investigative Site 1070 - Redding, California, United States
Anthos Investigative Site 1071 - San Dimas, California, United States
Anthos Investigative Site 1076 - Santa Ana, California, United States
Anthos Investigative Site 9938 - Santa Rosa, California, United States
Anthos Investigative Site 9908 - South Gate, California, United States
Anthos Investigative Site 9907 - Vista, California, United States
Anthos Investigative Site 1095 - Aurora, Colorado, United States
Anthos Investigative Site 1049 - Denver, Colorado, United States
Anthos Investigative Site 9922 - Golden, Colorado, United States
Anthos Investigative Site 1012 - Stamford, Connecticut, United States
Anthos Investigative Site 9934 - Altamonte Springs, Florida, United States
Anthos Investigative Site 1013 - Boca Raton, Florida, United States
Anthos Investigational site 9810 - Bradenton, Florida, United States
Anthos Investigational site 9818 - Clearwater, Florida, United States
Anthos Investigative Site 1025 - Clearwater, Florida, United States
Anthos Investigative Site 1022 - Clearwater, Florida, United States
Anthos Investigative Site 1019 - Daytona Beach, Florida, United States
Anthos Investigative Site 9936 - Hialeah, Florida, United States
Anthos Investigative Site 9804 - Hollywood, Florida, United States
Anthos Investigative Site 1083 - Hollywood, Florida, United States
Anthos Investigational site 9808 - Jacksonville, Florida, United States
Anthos Investigative Site 1008 - Jacksonville, Florida, United States
Anthos Investigational site 9813 - Jacksonville, Florida, United States
Anthos Investigational site 9828 - Jacksonville, Florida, United States
Anthos Investigative Site 9904 - Lake Mary, Florida, United States
Anthos Investigative Site 1093 - Lutz, Florida, United States
Anthos Investigative Site 9933 - Miami, Florida, United States
Anthos Investigational site 9823 - Miami Lakes, Florida, United States
Anthos Investigative Site 1072 - Miami Lakes, Florida, United States
Anthos Investigative Site 9944 - Ocala, Florida, United States
Anthos Investigative Site 9940 - Ocala, Florida, United States
Anthos Investigative Site 1067 - Ormond Beach, Florida, United States
Anthis Investigational site 9811 - Pensacola, Florida, United States
Anthos Investigational site9830 - Pensacola, Florida, United States
Anthos Investigational site 9802 - Port Orange, Florida, United States
Anthos Investigative Site 1026 - Safety Harbor, Florida, United States
Anthos Investigative Site 1002 - Saint Augustine, Florida, United States
Anthos Investigative Site 1004 - Saint Augustine, Florida, United States
Anthos Investigative Site 1044 - Tamarac, Florida, United States
Anthos Investigative Site 1088 - Tamarac, Florida, United States
Anthos Investigative Site 1046 - Tampa, Florida, United States
Anthos Investigative Site 9911 - The Villages, Florida, United States
Anthos Investigative Site 1052 - Lithonia, Georgia, United States
Anthos Investigative Site 1033 - Macon, Georgia, United States
Anthos Investigative Site 1042 - Norcross, Georgia, United States

Showing 60 of 789 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →