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)
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)
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply
novartis.email@novartis.com1-888-669-6682
Birmingham, Alabama 35205, United States
agilmore@uabmc.edu
Kansa City, Missouri 64151, United States
shari.gutto@avacare.com
Greensboro, North Carolina 27405, United States
Ciudad Autónoma Buenos Aires, 1061, Argentina
Ciudad Autónoma de Buenos Aire, 1027, Argentina
Ciudad Autónoma de Buenos Aire, 1428, Argentina
Saint Catharines, L2P 2W8, Canada
Liaoning, Liaoning 116001, China
Jinning, Shandong 272111, China
Shanxi, Shanxi 30001, China
ChongQing, Sichuan 400010, China
Henan Sheng, Zhengzhou Shi 450052, China
Ostrava - Poruba, 70868, Czechia
Haidari, WA 12462, Greece
Hyderabad, Andhra Pradesh 500012, India
Funabashi-Shi, 273-8588, Japan
Hamada-shi, 697-8511, Japan
Himeji-Shi, 670-0836, Japan
Isehara-Shi, 259-1193, Japan
Kure-shi, 737-8505, Japan
Matsumoto-Shi, 390-8621, Japan
Shimonoseki-shi, 752-8510, Japan
Tachikawa-shi, 190-0014, Japan
Uwajima-Shi, 798-8510, Japan
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eva.collins@primedphysicians.com
Aurora-Vera@ouhsc.edu
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