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

NCT07739888 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: ANT-010_OLE2023-503224-66-00
• Study Type: interventional
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

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)

Keywords

abelacimab; randomized; placebo-controlled; double-blind; endpoint evaluation; atrial fibrillation

Outcome Measures

Primary Outcomes (7)

• Time to first ISTH major Bleeding events

  Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events

  Up to 3 years

• Time to first BARC type 3c/5 bleeding

  Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding

  Up to 3 years

• Number of participants with ISTH major or CRNM bleeding

  Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding

  Up to 3 years

• Number of participants with bleeding

  All suspected bleeding events either reported by the patient or observed by the Investigator

  Up to 3 years

• Number of participants with TEAEs and TESAEs

  Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)

  Up to 3 years

• Number of participants with treatment discontinuations due to TEAEs

  Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)

  Up to 3 years

• Number of participants with device related AEs, SAEs, and device deficiencies

  Up to 3 years

Secondary Outcomes (1)

• Time to first event of ischemic stroke or SE

  Up to 3 years

Study Arms (1)

Abelacimab (MAA868)

EXPERIMENTAL

abelacimab 150 mg subcutaneous (SC)

Biological: Abelacimab

Interventions

Abelacimab BIOLOGICAL

Abelacimab provided as liquid in vial (150 mg/mL)

Also known as: MAA868

Abelacimab (MAA868)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

abelacimab; MAA868

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anthos Therapeutics a Novartis Company

CONTACT

1-888-669-6682; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): December 30, 2027
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share