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) (LILAC-TIMI 76)
Atrial Fibrillation (AF)
About this trial
This is an interventional treatment trial for Atrial Fibrillation (AF) focused on measuring abelacimab, randomized, placebo-controlled, double-blind, endpoint evaluation, atrial fibrillation
Eligibility Criteria
Inclusion Criteria: Patient is able to understand and willing to provide 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 ≥5 OR age ≥75 and a CHA2DS2VASc ≥4 Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulation 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 Exclusion Criteria: AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use) Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 60 days prior to randomization 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 Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- Anthos Investigative Site 1040Recruiting
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Abelacimab (MAA868)
Placebo
Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.