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)

Conditions

• Atrial Fibrillation (AF)

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Abelacimab — BIOLOGICAL
  Abelacimab provided as liquid in vial (150 mg/mL)
• Placebo — DRUG
  Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab

Study Details

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

Key Dates

Start date

Dec 27, 2022

Status verified

Feb 2026

Primary completion

Aug 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

1,900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Abelacimab (MAA868)
  Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
• Placebo Comparator: Placebo
  Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.

Primary Outcome Measure

Efficacy: Time to first event of ischemic stroke or systemic embolism (SE) [ Time Frame: Up to 30 months ]

Central Contacts

• Anthos Therapeutics a Novartis Company
  1-888-669-6682
  [email protected]

Locations (150)

Find similar trials in Birmingham, AL

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