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)
Anthos Therapeutics, Inc.
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 responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 s…
Interventions
- BiologicalAbelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
- DrugPlacebo
Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
Locations (734)
- Anthos Investigative Site 1040Birmingham, Alabama
- Anthos Investigational site 9939Birmingham, Alabama
- Anthos Investigative Site 9947Birmingham, Alabama
- Anthos Investigative Site 1041Mobile, Alabama
- Anthos Investigative Site 1089Gilbert, Arizona
- Anthos Investigative Site 1099Peoria, Arizona