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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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati789 centri35 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

  • Atrial Fibrillation (AF)

Idoneità

SessoTutti
Età65 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoDOUBLE (2)
Arruolamento2500 partecipanti ricercati

Sponsor e collaboratori

  • Anthos Therapeutics, Inc. Sponsor
  • Novartis Pharmaceuticals Collaboratori

Bracci e interventi

  • 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.

Interventi

  • Biologico Abelacimab

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

  • Farmaco Placebo

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

Esiti misurati

  1. Esito primario

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

    Undetermined strokes will be counted as ischemic strokes

    Orizzonte temporale Up to 30 months

  2. Esito primario

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

    Orizzonte temporale Up to 30 months

  3. Esito secondario

    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

    Orizzonte temporale Up to 30 months

  4. Esito secondario

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

    Orizzonte temporale Up to 30 months

  5. Esito secondario

    Efficacy: Cardiovascular (CV) mortality

    Orizzonte temporale Up to 30 months

  6. Esito secondario

    Efficacy: All-cause mortality

    Orizzonte temporale Up to 30 months

  7. Esito secondario

    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

    Orizzonte temporale Up to 30 months

Date

Data di inizio27 dicembre 2022 (effettiva)
Conclusione primaria30 dicembre 2027 (stimata)
Conclusione30 dicembre 2027 (stimata)
Prima pubblicazione3 febbraio 2023 (effettiva)
Ultimo aggiornamento13 luglio 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaluglio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

645 centri stanno reclutando

Argentina

StrutturaCittàStato o regioneStato
Anthos Investigational site 1400Bahía BlancaBuenos AiresIn reclutamento
Anthos Investigative Site 1430Buenos AiresIn reclutamento
Anthos Investigative Site 1411Buenos AiresIn reclutamento
Anthos Investigational site 1446Buenos AiresBuenos Aires F.D.In reclutamento
Anthos Investigational site 1443Buenos AiresBuenos Aires F.D.In reclutamento
Anthos Investigative Site 1409Ciudad Autónoma Buenos AiresIn reclutamento
Anthos Investigative Site 1410Ciudad Autónoma de Buenos AireIn reclutamento
Anthos Investigative Site 1423Ciudad Autónoma de Buenos AireIn reclutamento
Anthos Investigational site 1441CiudadelaBuenos AiresIn reclutamento
Anthos Investigative Site 1429Coronel SuárezIn reclutamento
Anthos Investigative Site 1420CorrientesIn reclutamento
Anthos Investigative Site 1431CórdobaIn reclutamento
Anthos Investigative Site 1407CórdobaIn reclutamento
Anthos Investigative Site 1418CórdobaIn reclutamento
Anthos Investigational site 1444CórdobaCórdoba ProvinceIn reclutamento
Anthos Investigative Site 1424CórdobaIn reclutamento
Anthos Investigative Site 1414CórdobaIn reclutamento
Anthos Investigative Site 1427CórdobaIn reclutamento
Anthos Investigative Site 1434CórdobaIn reclutamento
Anthos Investigative Site 1419CórdobaIn reclutamento
Anthos Investigational site 1438La PlataBuenos AiresIn reclutamento
Anthos Investigative Site 1402La PlataIn reclutamento
Anthos Investigative Site 1417QuilmesIn reclutamento
Anthos Investigative Site 1415Ramos MejíaIn reclutamento
Anthos Investigational site 1452SaltaSalta ProvinceIn reclutamento
Anthos Investigative Site 1403SaltaIn reclutamento
Anthos Investigative Site 1425San LuisIn reclutamento
Anthos Investigative Site 1426San MartinIn reclutamento
Anthos Investigational site 1449San Miguel de TucumánTucumán ProvinceIn reclutamento
Anthos Investigational site 1451San Miguel de TucumánIn reclutamento
Anthos Investigative Site 1435San Miguel de TucumánIn reclutamento
Anthos Investigative Site 1404San Miguel de TucumánIn reclutamento
Anthos Investigative Site 1436San NicolásIn reclutamento
Anthos Investigational site 1445TemperleyBuenos AiresIn reclutamento
Anthos Investigational site 1439Villa MaríaCórdoba ProvinceIn reclutamento

Brazil

StrutturaCittàStato o regioneStato
Anthos Investigative Site 1518AracajuIn reclutamento
Anthos Investigative Site 1516Belo HorizonteRitirato
Anthos Investigative Site 1507Belo HorizonteIn reclutamento
Anthos Investigative Site 1527Belo HorizonteIn reclutamento
Anthos Investigative Site 1528Belo HorizonteIn reclutamento
Anthos Investigative Site 1513BlumenauIn reclutamento
Anthos Investigative Site 1505BlumenauIn reclutamento
Anthos Investigative Site 1535BrasíliaIn reclutamento
Anthos Investigative Site 1501Campina Grande do SulIn reclutamento
Anthos Investigative Site 1522CampinasIn reclutamento
Anthos Investigative Site 1503CampinasRitirato
Anthos Investigative Site 1520Campo GrandeIn reclutamento
Anthos Investigative Site 1532CanoasIn reclutamento
Anthos Investigative Site 1526Caxias do SulIn reclutamento
Anthos Investigative Site 1542ColatinaIn reclutamento

Nella scheda del registro sono indicati altri 739 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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