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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)

A study of abelacimab in patients with atrial fibrillation deemed unsuitable for oral anticoagulation (LILAC)

Kinumura Takumi

Fortrea Japan K.K.

Harumi Triton Square Office Tower Y 8F 1-8-11, Harumi, Chuo-ku, Tokyo 104-6108 Japan

Takumi.Kinumura@fortrea.com

Kinumura Takumi

Fortrea Japan K.K.

Harumi Triton Square Office Tower Y 8F 1-8-11, Harumi, Chuo-ku, Tokyo 104-6108 Japan

+81-90-7194-4061

Takumi.Kinumura@fortrea.com

Recruiting

May. 23, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Patient is able to understand and has provideded written informed consent to participate in the trial
- Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
- Age 65-74 and a CHA2DS2VASc greater than or equal 4 OR age greater than or equal 75 and a CHA2DS2VASc greater than or equal 3
- Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
- At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls
- Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study

- AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
- Patients who within 60 days prior to randomization (1) received a VKA (e.g., warfarin, phenprocoumon, acenocoumarol) or a DOAC such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
- Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
- Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization
- Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
-Patients on dialysis at screening or who are planned to start dialysis within 6 months

Both

Atrial Fibrillation

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

Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding

+81-3-6262-2811

April. 14, 2023

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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