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NCT05712200ClinicalTrials.gov

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)

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)

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En resumen

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…

Fase 32500 participantes buscados789 centros35 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 38 days after the recorded start)First posted 2023-02-03; recorded start 2022-12-27
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 7 other studies in this databaseCounted from the lead sponsor named in the record (Anthos Therapeutics, Inc.)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding13/20

    Double-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type7/10

    Clinical-event endpoint

  • Multi-centre8/8

    Multi-centre: 789 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 2,500 participants (target), run at 789 sites, across 35 countries.

How this score is built
  • Enrolment34/40

    2,500 participants (target)

  • Site count25/25

    789 sites

  • Country count15/15

    35 countries

  • Planned duration10/10

    Planned over about 61 months

  • Sponsor scale3/10

    Anthos Therapeutics, Inc. has led 8 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Patients enrolled in the study are randomized in a 1:1 ratio to receive abelacimab 150 mg SC or matching placebo once monthly. The study is comprised of 3 periods: 1) screening period of up to 60 days, 2) an event-driven, double-blind treatment period (abelacimab 150 mg SC or matching placebo) completed after at least 111 patients have experienced an adjudicated primary endpoint event, and 3) EoT visit in core part followed by either (i) a 30-day follow-up period (EoS for core part) OR (ii) an optional OLE beginning at the EoT visit for eligible patients to receive open-label abelacimab treatment. The optional extension will only be offered to patients following regulatory and ethics approval in participating countries.

Afecciones

  • Atrial Fibrillation (AF)

Elegibilidad

SexoTodos
Edades65 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Patient is able to understand and has provided 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 ≥4 OR age ≥75 and a CHA2DS2VASc ≥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 Exclusion Criteria: * 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 vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (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 Other protocol defined Inclusion/Exclusion criteria may apply

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoDOUBLE (2)
Inscripción2500 participantes buscados

Patrocinador y colaboradores

  • Anthos Therapeutics, Inc. Patrocinador
  • Novartis Pharmaceuticals Colaboradores

Grupos e intervenciones

  • Abelacimab (MAA868)EXPERIMENTAL

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

  • PlaceboPLACEBO_COMPARATOR

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

Intervenciones

  • Biológico Abelacimab

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

  • Fármaco Placebo

    Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab

Variables de resultado

  1. Variable de resultado principal

    Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)

    Undetermined strokes will be counted as ischemic strokes

    Plazo Up to 30 months

  2. Variable de resultado principal

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

    Plazo Up to 30 months

  3. Variable de resultado secundaria

    Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), myocardial infarctions (MI), venous thromboembolism (VTE), or acute limb ischemia

    Abelacimab versus placebo with regard to the composite of ischemic stroke, SE, MI, VTE, or acute limb ischemia

    Plazo Up to 30 months

  4. Variable de resultado secundaria

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

    Plazo Up to 30 months

  5. Variable de resultado secundaria

    Efficacy: Cardiovascular (CV) mortality

    Plazo Up to 30 months

  6. Variable de resultado secundaria

    Efficacy: All-cause mortality

    Plazo Up to 30 months

  7. Variable de resultado secundaria

    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

    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

    Plazo Up to 30 months

Fechas

Fecha de inicio27 de diciembre de 2022 (real)
Finalización principal30 de diciembre de 2027 (estimada)
Finalización30 de diciembre de 2027 (estimada)
Primera publicación3 de febrero de 2023 (real)
Última actualización13 de julio de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjulio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

645 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Anthos Investigational site 1400Bahía BlancaBuenos AiresEn reclutamiento
Anthos Investigative Site 1430Buenos AiresEn reclutamiento
Anthos Investigative Site 1411Buenos AiresEn reclutamiento
Anthos Investigational site 1446Buenos AiresBuenos Aires F.D.En reclutamiento
Anthos Investigational site 1443Buenos AiresBuenos Aires F.D.En reclutamiento
Anthos Investigative Site 1409Ciudad Autónoma Buenos AiresEn reclutamiento
Anthos Investigative Site 1410Ciudad Autónoma de Buenos AireEn reclutamiento
Anthos Investigative Site 1423Ciudad Autónoma de Buenos AireEn reclutamiento
Anthos Investigational site 1441CiudadelaBuenos AiresEn reclutamiento
Anthos Investigative Site 1429Coronel SuárezEn reclutamiento
Anthos Investigative Site 1420CorrientesEn reclutamiento
Anthos Investigative Site 1431CórdobaEn reclutamiento
Anthos Investigative Site 1407CórdobaEn reclutamiento
Anthos Investigative Site 1418CórdobaEn reclutamiento
Anthos Investigational site 1444CórdobaCórdoba ProvinceEn reclutamiento
Anthos Investigative Site 1424CórdobaEn reclutamiento
Anthos Investigative Site 1414CórdobaEn reclutamiento
Anthos Investigative Site 1427CórdobaEn reclutamiento
Anthos Investigative Site 1434CórdobaEn reclutamiento
Anthos Investigative Site 1419CórdobaEn reclutamiento
Anthos Investigational site 1438La PlataBuenos AiresEn reclutamiento
Anthos Investigative Site 1402La PlataEn reclutamiento
Anthos Investigative Site 1417QuilmesEn reclutamiento
Anthos Investigative Site 1415Ramos MejíaEn reclutamiento
Anthos Investigational site 1452SaltaSalta ProvinceEn reclutamiento
Anthos Investigative Site 1403SaltaEn reclutamiento
Anthos Investigative Site 1425San LuisEn reclutamiento
Anthos Investigative Site 1426San MartinEn reclutamiento
Anthos Investigational site 1449San Miguel de TucumánTucumán ProvinceEn reclutamiento
Anthos Investigational site 1451San Miguel de TucumánEn reclutamiento
Anthos Investigative Site 1435San Miguel de TucumánEn reclutamiento
Anthos Investigative Site 1404San Miguel de TucumánEn reclutamiento
Anthos Investigative Site 1436San NicolásEn reclutamiento
Anthos Investigational site 1445TemperleyBuenos AiresEn reclutamiento
Anthos Investigational site 1439Villa MaríaCórdoba ProvinceEn reclutamiento

Brazil

CentroCiudadEstado o regiónEstado
Anthos Investigative Site 1518AracajuEn reclutamiento
Anthos Investigative Site 1516Belo HorizonteRetirado
Anthos Investigative Site 1507Belo HorizonteEn reclutamiento
Anthos Investigative Site 1527Belo HorizonteEn reclutamiento
Anthos Investigative Site 1528Belo HorizonteEn reclutamiento
Anthos Investigative Site 1513BlumenauEn reclutamiento
Anthos Investigative Site 1505BlumenauEn reclutamiento
Anthos Investigative Site 1535BrasíliaEn reclutamiento
Anthos Investigative Site 1501Campina Grande do SulEn reclutamiento
Anthos Investigative Site 1522CampinasEn reclutamiento
Anthos Investigative Site 1503CampinasRetirado
Anthos Investigative Site 1520Campo GrandeEn reclutamiento
Anthos Investigative Site 1532CanoasEn reclutamiento
Anthos Investigative Site 1526Caxias do SulEn reclutamiento
Anthos Investigative Site 1542ColatinaEn reclutamiento

En el registro figuran 739 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05712200