Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral... | NCT07739888

NCT07739888

Overview

NCT ID: NCT07739888
Lead Sponsor: Novartis PharmaceuticalsINDUSTRY
Official Title: 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)
Brief Summary: 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)
Conditions: Atrial Fibrillation (AF)
Interventions

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients are able to provide written informed consent to enter the extension part.

Patients must be on study treatment at the time of EoT visit in the core part.

Exclusion Criteria:

Patients meeting any exclusion criteria in the core part.

Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation

History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes

Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study.

Other protocol defined Inclusion/Exclusion criteria may apply

Central Contacts: Anthos Therapeutics a Novartis CompanyContact
novartis.email@novartis.com