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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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 32 500 participants recherchés789 sites35 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Atrial Fibrillation (AF)

Éligibilité

SexeTous
Âges65 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuDOUBLE (2)
Recrutement2 500 participants recherchés

Promoteur et collaborateurs

  • Anthos Therapeutics, Inc. Promoteur
  • Novartis Pharmaceuticals Collaborateurs

Groupes et interventions

  • 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.

Interventions

  • Produit biologique Abelacimab

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

  • Médicament Placebo

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

Critères de jugement

  1. Critère de jugement principal

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

    Undetermined strokes will be counted as ischemic strokes

    Délai Up to 30 months

  2. Critère de jugement principal

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

    Délai Up to 30 months

  3. Critère de jugement secondaire

    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

    Délai Up to 30 months

  4. Critère de jugement secondaire

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

    Délai Up to 30 months

  5. Critère de jugement secondaire

    Efficacy: Cardiovascular (CV) mortality

    Délai Up to 30 months

  6. Critère de jugement secondaire

    Efficacy: All-cause mortality

    Délai Up to 30 months

  7. Critère de jugement secondaire

    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

    Délai Up to 30 months

Dates

Date de début27 décembre 2022 (réelle)
Achèvement principal30 décembre 2027 (estimée)
Achèvement30 décembre 2027 (estimée)
Première publication3 février 2023 (réelle)
Dernière mise à jour13 juillet 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

645 sites sont en recrutement

Argentina

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

Brazil

ÉtablissementVilleÉtat ou régionStatut
Anthos Investigative Site 1518AracajuEn recrutement
Anthos Investigative Site 1516Belo HorizonteRetiré
Anthos Investigative Site 1507Belo HorizonteEn recrutement
Anthos Investigative Site 1527Belo HorizonteEn recrutement
Anthos Investigative Site 1528Belo HorizonteEn recrutement
Anthos Investigative Site 1513BlumenauEn recrutement
Anthos Investigative Site 1505BlumenauEn recrutement
Anthos Investigative Site 1535BrasíliaEn recrutement
Anthos Investigative Site 1501Campina Grande do SulEn recrutement
Anthos Investigative Site 1522CampinasEn recrutement
Anthos Investigative Site 1503CampinasRetiré
Anthos Investigative Site 1520Campo GrandeEn recrutement
Anthos Investigative Site 1532CanoasEn recrutement
Anthos Investigative Site 1526Caxias do SulEn recrutement
Anthos Investigative Site 1542ColatinaEn recrutement

739 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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