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Clinical Trials in India / NCT05712200
Recruiting Phase 3

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)

NCT05712200 · tracked via the Priya Life Science India tracker
Sponsor
Anthos Therapeutics, Inc.
Phase
Phase 3
Started
2022-12-27
Last updated
2026-07-13

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

AbelacimabPlacebo

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

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

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (789)

FacilityCityRegionStatus
Anthos Investigative Site 1040 Birmingham Alabama Recruiting
Anthos Investigational site 9939 Birmingham Alabama Recruiting
Anthos Investigative Site 9947 Birmingham Alabama Not Yet Recruiting
Anthos Investigative Site 1041 Mobile Alabama Recruiting
Anthos Investigative Site 1089 Gilbert Arizona Withdrawn
Anthos Investigative Site 1099 Peoria Arizona Recruiting
Anthos Investigative Site 9906 Phoenix Arizona Recruiting
Anthos Investigative Site 9927 Yuma Arizona Recruiting
Anthos Investigative Site 9929 Huntington Beach California Recruiting
Anthos Investigative Site 9959 Imperial California Recruiting
Anthos Investigative Site 9921 Lancaster California Recruiting
Anthos Investigative Site 1078 Loma Linda California Recruiting
Anthos Investigative Site 1077 Los Angeles California Recruiting
Anthos Investigative Site 1015 Northridge California Withdrawn
Anthos Investigational site 9821 Orange California Recruiting
Anthos Investigative Site 1070 Redding California Active Not Recruiting
Anthos Investigative Site 1071 San Dimas California Recruiting
Anthos Investigative Site 1076 Santa Ana California Withdrawn
Anthos Investigative Site 9938 Santa Rosa California Recruiting
Anthos Investigative Site 9908 South Gate California Recruiting
Anthos Investigative Site 9907 Vista California Recruiting
Anthos Investigative Site 1095 Aurora Colorado Recruiting
Anthos Investigative Site 1049 Denver Colorado Withdrawn
Anthos Investigative Site 9922 Golden Colorado Recruiting
Anthos Investigative Site 1012 Stamford Connecticut Recruiting
Anthos Investigative Site 9934 Altamonte Springs Florida Recruiting
Anthos Investigative Site 1013 Boca Raton Florida Recruiting
Anthos Investigational site 9810 Bradenton Florida Recruiting
Anthos Investigational site 9818 Clearwater Florida Recruiting
Anthos Investigative Site 1025 Clearwater Florida Recruiting
Anthos Investigative Site 1022 Clearwater Florida Recruiting
Anthos Investigative Site 1019 Daytona Beach Florida Recruiting
Anthos Investigative Site 9936 Hialeah Florida Recruiting
Anthos Investigative Site 9804 Hollywood Florida Recruiting
Anthos Investigative Site 1083 Hollywood Florida Recruiting
Anthos Investigational site 9808 Jacksonville Florida Recruiting
Anthos Investigative Site 1008 Jacksonville Florida Withdrawn
Anthos Investigational site 9813 Jacksonville Florida Recruiting
Anthos Investigational site 9828 Jacksonville Florida Recruiting
Anthos Investigative Site 9904 Lake Mary Florida Recruiting

+ 749 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05712200 on ClinicalTrials.gov ↗ ← All trials in India