Actively Recruiting
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Unsuitable for Oral Anticoagulation
Led by Anthos Therapeutics, Inc. · Updated on 2026-03-31
1900
Participants Needed
734
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Anthos Therapeutics, Inc.
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of abelacimab compared to a placebo on reducing the rate of ischemic stroke or systemic embolism in patients with atrial fibrillation who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients, including those who may have increased bleeding risks and cannot or choose not to take standard blood thinners. Participants will be randomly assigned to receive either abelacimab 150 mg or a matching placebo through a monthly subcutaneous injection. The study is designed as a double-blind, placebo-controlled trial to monitor the safety and efficacy of abelacimab over a period of up to 30 months. During the study, participants will be closely monitored for the time to first occurrence of ischemic stroke, systemic embolism, and bleeding events classified by the Bleeding Academic Research Consortium. Researchers will also track cardiovascular and all-cause mortality, as well as other cardiovascular events. Participants will undergo regular assessments, including electrocardiograms and clinical evaluations, throughout the trial to ensure safety and collect data on treatment effects.
CONDITIONS
Brief 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with a CHA2DS2VASc score of 4 or higher, or age 75 and older with a CHA2DS2VASc score of 3 or higher
- Judged by responsible physician to be unsuitable for oral anticoagulation due to risk outweighing benefits or patient unwilling to take it, with this decision made before and independent of the study
- Has at least one bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication during the trial, history of bleeding from a critical area, chronic NSAID use, frailty, or multiple falls
- Judged by responsible physician to be unsuitable for left atrial appendage closure or occlusion device, approved device not available, or patient unwilling to undergo the procedure, with this decision made before and independent of the study
You will not qualify if you...
- Atrial fibrillation due to an ongoing acute reversible cause such as cardiac surgery, pulmonary embolism, untreated hyperthyroidism, or alcohol use
- Received vitamin K antagonists or direct oral anticoagulants within 60 days prior to randomization, or newly diagnosed with AF within that period
- Intracranial or intraocular bleeding within 3 months prior to screening or any history of spontaneous intracerebral hemorrhage without antithrombotic treatment
- Stroke within 14 days or transient ischemic attack (TIA) within 3 days before randomization
- Mechanical heart valve or valve disease expected to require mechanical valve replacement during the study
- Patients on dialysis at screening or planned to start dialysis within 6 months
- Other protocol-defined inclusion or exclusion criteria may apply
Research Team
A
Anthos Therapeutics a Novartis Company
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