Last updated 28 days ago
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)
2500 patients around the world
Available in United States, Brazil, Argentina
Patients enrolled in the study are randomized in a 1:1 ratio to receive abelacimab 150 mg SC or matching placebo once monthly. The study is comprised of 3 periods: 1) screening period of up to 60 days, 2) an event-driven, double-blind treatment period (abelacimab 150 mg SC or matching placebo) completed after at least 111 patients have experienced an adjudicated primary endpoint event, and 3) EoT visit in core part followed by either (i) a 30-day follow-up period (EoS for core part) OR (ii) an optional OLE beginning at the EoT visit for eligible patients to receive open-label abelacimab treatment. The optional extension will only be offered to patients following regulatory and ethics approval in participating countries.
Anthos Therapeutics, Inc.
2Research sites
2500Patients around the world
This study is for people with
Cardiac arrhythmia
Atrial fibrillation
Requirements for the patient
From 65 Years
All Gender
Medical requirements
- Patient is able to understand and willing to provide written informed consent to participate in the trialDiagnosed 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 ≥4Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulationAt 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
- 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 randomizationPatients 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 treatmentAny stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomizationMechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
Sites
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Hospital Universidad del Norte
Recruiting
StudyLILAC-TIMI 76
SponsorAnthos Therapeutics, Inc.
Study typeInterventional
Conditions
Atrial fibrillation
Requirements
From 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05712200
