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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) (LILAC-TIMI 76)

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ClinicalTrials.gov Identifier: NCT05712200
Recruitment Status : Recruiting
First Posted : February 3, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Anthos Therapeutics, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation (AF) Biological: Abelacimab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : December 27, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : March 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Abelacimab (MAA868)
Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
 Biological: Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
Other Name: MAA868
Placebo Comparator: Placebo
Patients will be randomized in a 1:1 ratio to receive abelacimab 150 mg subcutaneous (SC) or matching placebo once monthly.
 Drug: Placebo

Dosage Formulation: Liquid (in vial)

Dose Strength: Placebo to Abelacimab


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy: Time to first event of ischemic stroke or systemic embolism (SE) [ Time Frame: Up to 30 months ]
  2. Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding [ Time Frame: Up to 30 months ]

Secondary Outcome Measures :
  1. Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia [ Time Frame: Up to 30 months ]
    Abelacimab versus placebo with regard to the composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia

  2. Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event [ Time Frame: Up to 30 months ]
  3. Efficacy: Cardiovascular (CV) mortality [ Time Frame: Up to 30 months ]
  4. Efficacy: All-cause mortality [ Time Frame: Up to 30 months ]
  5. Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding [ Time Frame: Up to 30 months ]
    Abelacimab versus placebo with regard to net clinical outcome defined as the composite of ischemic stroke, SE, MI, VTE, acute limb ischemia, or International Society on Thrombosis and Haemostasis (ISTH) major bleeding


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is able to understand and willing to provide 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 ≥5 OR age ≥75 and a CHA2DS2VASc ≥4
  • Judged by the responsible physician or by their own decision to be unsuitable for oral anticoagulation
  • 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

Exclusion Criteria:

  • AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)
  • Patients who received warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban within 60 days prior to randomization
  • 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

Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05712200


Contacts
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Contact: Anthos Therapeutics +1 617 430 6940 clinicaltrials@anthostherapeutics.com

Locations
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Sponsors and Collaborators
Anthos Therapeutics, Inc.
More Information
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Responsible Party: Anthos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05712200    
Other Study ID Numbers: ANT-010
First Posted: February 3, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthos Therapeutics, Inc.:
abelacimab
randomized
placebo-controlled
 double-blind
endpoint evaluation
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes