Status:
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)
Lead Sponsor:
Anthos Therapeutics, Inc.
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
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 respon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT05712200
Start Date
December 27 2022
End Date
October 31 2026
Last Update
February 13 2026
Active Locations (721)
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1
Anthos Investigative Site 1040
Birmingham, Alabama, United States, 35205
2
Anthos Investigational site 9939
Birmingham, Alabama, United States, 35233
3
Anthos Investigative Site 9947
Birmingham, Alabama, United States, 35243
4
Anthos Investigative Site 1041
Mobile, Alabama, United States, 36608