Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation
Starting soon · Phase 3
Conditions studied: Atrial Fibrillation (AF)
In brief
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)
Key facts
- Study ID
- NCT07739888
- Run by
- Novartis Pharmaceuticals
- People needed
- 2500
- Starts
- 2027-12-30
- Expected to finish
- 2030-12-30
- Last updated by the study team
- 2026-07-31
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Full record on ClinicalTrials.gov
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