Testing Abelacimab against a placebo for atrial fibrillation (AF)
Official 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)
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)
Interventions
Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Placebo
Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
Canadian Sites (24)
Anthos Investigative Site 2016
Abbotsford British Columbia, Canada
Anthos Investigative Site 2019
Brampton, Canada
Anthos Investigative Site 2015
Edmonton, Canada
Anthos Investigative Site 2018
Greenfield Park, Canada
Anthos Investigative Site 2005
Halifax, Canada
Anthos Investigative Site 2025
Hamilton, Canada
Anthos Investigative Site 2026
Hamilton, Canada
Anthos Investigative Site 2028
Markham, Canada
Anthos Investigative Site 2014
Montreal, Canada
Anthos Investigative Site 2004
New Westminster, Canada
Anthos Investigative Site 2021
North Vancouver, Canada
Anthos Investigative Site 2002
Québec, Canada
Anthos Investigative Site 2024
Saint Catharines, Canada
Anthos Investigative Site 2006
Saint-Jérôme, Canada
Anthos Investigative Site 2027
Terrebonne, Canada
Anthos Investigative Site 2022
Thunder Bay, Canada
Anthos Investigative Site 2017
Toronto, Canada
Anthos Investigative Site 2020
Toronto, Canada
Anthos Investigative Site 2023
Toronto, Canada
Anthos Investigative Site 2012
Mira Road, Nova Scotia, Canada
Anthos Investigative Site 2003
Cambridge, Ontario, Canada
Anthos Investigational site 2029
London, Ontario, Canada
Anthos Investigative Site 2007
Chicoutimi, Quebec, Canada
Anthos Investigative Site 2010
Sherbrooke, Quebec, Canada
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
- +Patient is able to understand and has provided written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the trial
- +Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
- +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
- −Patients who within 60 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 protocolProtocolThe detailed plan a study must follow.Read more → defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply
- −AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Abelacimab, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 65 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,500 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Up to 30 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE) — measured over Up to 30 months.
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding — measured over Up to 30 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05712200 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AbelacimabBiological
Abelacimab provided as liquid in vial (150 mg/mL)
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PlaceboDrug
Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 65 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 30 months.
The study as a whole is currently expected to finish around 2027-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 35 locations, including: Abbotsford British Columbia, Canada; Brampton, Canada; Edmonton, Canada; Greenfield Park, Canada; Halifax, Canada; Hamilton, Canada, and 29 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (15)
Anthos Investigational site 9819
Lansing, Michigan, United States
Anthos Investigative Site 1021
Lansing, Michigan, United States
Anthos Investigative Site 9946
Petoskey, Michigan, United States
Anthos Investigative Site 1059
Southgate, Michigan, United States
Anthos Investigative Site 9931
Albany, New York, United States
Anthos Investigative Site 9905
Brooklyn, New York, United States
Anthos Investigational site 9829
Hauppauge, New York, United States
Anthos Investigative Site 1014
Middletown, New York, United States
Anthos Investigative Site 1037
Rosedale, New York, United States
Anthos Investigative Site 9935
Stony Brook, New York, United States
Anthos Investigative Site 9920
Valhalla, New York, United States
Anthos Investigative Site 9924
Westfield, New York, United States
Anthos Investigational site 9826
Puyallup, Washington, United States
Anthos Investigative Site 9926
Redmond, Washington, United States
Anthos Investigative Site 1073
Tacoma, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.