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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503224-66-00

Acronym

ANT-010

Enrollment

1164

Registered

2023-06-12

Start date

2023-10-31

Completion date

Unknown

Last updated

2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

The primary efficacy endpoint is the time to first occurrence of confirmed ischemic stroke or SE., The primary safety endpoint is the time to first occurrence of adjudicated BARC type 3c/5 bleeding. Other safety endpoints include: • ISTH major bleeding • BARC type 3b/3c/5 bleeding • ISTH major and clinically relevant nonmajor (CRNM) bleeding • All bleeding"

Detailed description

The secondary efficacy endpoints include: • Composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia • Composite of ischemic stroke, SE, or BARC type 3c/5 bleeding • Cardiovascular (CV) mortality • All-cause mortality • Composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or ISTH major bleeding"

Interventions

DRUGPlacebo 0 mg/1mL solution for infusion/injection

DRUGmatching abelacimab

DRUGAbelacimab 150 mg/ml solution for infusion

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the time to first occurrence of confirmed ischemic stroke or SE., The primary safety endpoint is the time to first occurrence of adjudicated BARC type 3c/5 bleeding. Other safety endpoints include: • ISTH major bleeding • BARC type 3b/3c/5 bleeding • ISTH major and clinically relevant nonmajor (CRNM) bleeding • All bleeding"	—

Secondary

Measure	Time frame
The secondary efficacy endpoints include: • Composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia • Composite of ischemic stroke, SE, or BARC type 3c/5 bleeding • Cardiovascular (CV) mortality • All-cause mortality • Composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or ISTH major bleeding"	—

Countries

Bulgaria, Croatia, Czechia, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026