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NCT Number: NCT07739888

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

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)

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Patients who provide consent, will need to complete the end of treatment visit (EoT) assessments of the Core Part of CMAA868A2302 (ANT-010/NCT05712200) prior to receiving first dose in the OLE. Day 1 visit or dosing should occur on same day as EoT visit to avoid treatment interruption.

Participation in OLE will end if a patient permanently discontinues study treatment, or the study is completed or terminated by the Sponsor.

All patients will need to complete End of Study in Extension visit in person followed by a phone call visit 30 days after End of Extension visit. Any updates in AE or concomitant medications will be reported by a phone call/video call visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abelacimab

Biological

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

Other names: MAA868

Primary outcomes

  1. Time to first ISTH major Bleeding events

    Time frame: Up to 3 years

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

  2. Time to first BARC type 3c/5 bleeding

    Time frame: Up to 3 years

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

  3. Number of participants with ISTH major or CRNM bleeding

    Time frame: Up to 3 years

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

  4. Number of participants with bleeding

    Time frame: Up to 3 years

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

  5. Number of participants with TEAEs and TESAEs

    Time frame: Up to 3 years

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

  6. Number of participants with treatment discontinuations due to TEAEs

    Time frame: Up to 3 years

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

  7. Number of participants with device related AEs, SAEs, and device deficiencies

    Time frame: Up to 3 years

Secondary outcomes

  1. Time to first event of ischemic stroke or SE

    Time frame: Up to 3 years

    Time to first event of ischemic stroke or systemic embolism (SE). Undetermined strokes will be counted as ischemic strokes

Study contacts

Contact information is provided by the study sponsor or research team.

Anthos Therapeutics a Novartis Company

CONTACT

[email protected]

1-888-669-6682

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: LILAC-TIMI 76

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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