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Phase 3Not yet recruitingAge-related condition

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)

Sponsor
Novartis Pharmaceuticals (Industry)
Enrollment
2,500 planned
Conditions
Atrial Fibrillation (AF)
Interventions
Abelacimab
Ages
older adults
Registry
NCT07739888, CTIS2023-503224-66-00

Full record on ClinicalTrials.gov

From the registry

This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)

Primary outcomes

  • Time to first ISTH major Bleeding events
  • Time to first BARC type 3c/5 bleeding
  • Number of participants with ISTH major or CRNM bleeding
  • Number of participants with bleeding

History

  1. Primary completion expected

  2. Expected to start

  3. Registered