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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorNovartis Pharmaceuticals

About this trial

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)

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Abelacimab

Treatment groups

2,500 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators