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)

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 2,500 مشارك789 موقعاً35 دولة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT05712200فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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هل أنت مهتم بهذه الدراسة؟

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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.

Not stated: Registered after enrolment began (about 38 days after the recorded start)First posted 2023-02-03; recorded start 2022-12-27
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 7 other studies in this databaseCounted from the lead sponsor named in the record (Anthos Therapeutics, Inc.)
Present: 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.

ملخص

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.

الحالات

Atrial Fibrillation (AF)

الأهلية

الأهلية
الجنس	الجميع
الأعمار	65 Years – لا حد أقصى
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	المرحلة 3
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	DOUBLE (2)
التجنيد	مطلوب 2,500 مشارك

الجهة الراعية والمتعاونون

Anthos Therapeutics, Inc. الجهة الراعية
Novartis Pharmaceuticals المتعاونون

الأذرع والتدخلات

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.

التدخلات

منتج بيولوجي Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
دواء Placebo
Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab

مقاييس النتائج

مقياس النتيجة الأولي
Efficacy: Time to first event of ischemic stroke or systemic embolism (SE)
Undetermined strokes will be counted as ischemic strokes
الإطار الزمني Up to 30 months
مقياس النتيجة الأولي
Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
الإطار الزمني Up to 30 months
مقياس النتيجة الثانوي
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
الإطار الزمني Up to 30 months
مقياس النتيجة الثانوي
Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event
الإطار الزمني Up to 30 months
مقياس النتيجة الثانوي
Efficacy: Cardiovascular (CV) mortality
الإطار الزمني Up to 30 months
مقياس النتيجة الثانوي
Efficacy: All-cause mortality
الإطار الزمني Up to 30 months
مقياس النتيجة الثانوي
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
الإطار الزمني Up to 30 months

التواريخ

التواريخ
تاريخ البدء	27 ديسمبر 2022 (فعلي)
الإتمام الأولي	30 ديسمبر 2027 (تقديري)
الإتمام	30 ديسمبر 2027 (تقديري)
أول نشر	3 فبراير 2023 (فعلي)
آخر تحديث	13 يوليو 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	يوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

645 موقعاً قيد التجنيد

Argentina

Argentina
المنشأة	المدينة	الولاية أو المنطقة	الحالة
Anthos Investigational site 1400	Bahía Blanca	Buenos Aires	قيد التجنيد
Anthos Investigative Site 1430	Buenos Aires		قيد التجنيد
Anthos Investigative Site 1411	Buenos Aires		قيد التجنيد
Anthos Investigational site 1446	Buenos Aires	Buenos Aires F.D.	قيد التجنيد
Anthos Investigational site 1443	Buenos Aires	Buenos Aires F.D.	قيد التجنيد
Anthos Investigative Site 1409	Ciudad Autónoma Buenos Aires		قيد التجنيد
Anthos Investigative Site 1410	Ciudad Autónoma de Buenos Aire		قيد التجنيد
Anthos Investigative Site 1423	Ciudad Autónoma de Buenos Aire		قيد التجنيد
Anthos Investigational site 1441	Ciudadela	Buenos Aires	قيد التجنيد
Anthos Investigative Site 1429	Coronel Suárez		قيد التجنيد
Anthos Investigative Site 1420	Corrientes		قيد التجنيد
Anthos Investigative Site 1431	Córdoba		قيد التجنيد
Anthos Investigative Site 1407	Córdoba		قيد التجنيد
Anthos Investigative Site 1418	Córdoba		قيد التجنيد
Anthos Investigational site 1444	Córdoba	Córdoba Province	قيد التجنيد
Anthos Investigative Site 1424	Córdoba		قيد التجنيد
Anthos Investigative Site 1414	Córdoba		قيد التجنيد
Anthos Investigative Site 1427	Córdoba		قيد التجنيد
Anthos Investigative Site 1434	Córdoba		قيد التجنيد
Anthos Investigative Site 1419	Córdoba		قيد التجنيد
Anthos Investigational site 1438	La Plata	Buenos Aires	قيد التجنيد
Anthos Investigative Site 1402	La Plata		قيد التجنيد
Anthos Investigative Site 1417	Quilmes		قيد التجنيد
Anthos Investigative Site 1415	Ramos Mejía		قيد التجنيد
Anthos Investigational site 1452	Salta	Salta Province	قيد التجنيد
Anthos Investigative Site 1403	Salta		قيد التجنيد
Anthos Investigative Site 1425	San Luis		قيد التجنيد
Anthos Investigative Site 1426	San Martin		قيد التجنيد
Anthos Investigational site 1449	San Miguel de Tucumán	Tucumán Province	قيد التجنيد
Anthos Investigational site 1451	San Miguel de Tucumán		قيد التجنيد
Anthos Investigative Site 1435	San Miguel de Tucumán		قيد التجنيد
Anthos Investigative Site 1404	San Miguel de Tucumán		قيد التجنيد
Anthos Investigative Site 1436	San Nicolás		قيد التجنيد
Anthos Investigational site 1445	Temperley	Buenos Aires	قيد التجنيد
Anthos Investigational site 1439	Villa María	Córdoba Province	قيد التجنيد

Brazil

Brazil
المنشأة	المدينة	الحالة
Anthos Investigative Site 1518	Aracaju	قيد التجنيد
Anthos Investigative Site 1516	Belo Horizonte	مسحوب
Anthos Investigative Site 1507	Belo Horizonte	قيد التجنيد
Anthos Investigative Site 1527	Belo Horizonte	قيد التجنيد
Anthos Investigative Site 1528	Belo Horizonte	قيد التجنيد
Anthos Investigative Site 1513	Blumenau	قيد التجنيد
Anthos Investigative Site 1505	Blumenau	قيد التجنيد
Anthos Investigative Site 1535	Brasília	قيد التجنيد
Anthos Investigative Site 1501	Campina Grande do Sul	قيد التجنيد
Anthos Investigative Site 1522	Campinas	قيد التجنيد
Anthos Investigative Site 1503	Campinas	مسحوب
Anthos Investigative Site 1520	Campo Grande	قيد التجنيد
Anthos Investigative Site 1532	Canoas	قيد التجنيد
Anthos Investigative Site 1526	Caxias do Sul	قيد التجنيد
Anthos Investigative Site 1542	Colatina	قيد التجنيد

يُدرَج 739 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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