RECRUITINGPhase 3INTERVENTIONAL
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)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patient is able to understand and has provided written willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
Abelacimab
Abelacimab provided as liquid in vial (150 mg/mL)
DRUG
Placebo
Dosage Formulation: Liquid (in vial) Dose Strength: Placebo to Abelacimab
Locations (20)
Anthos Investigative Site 1040
Birmingham, Alabama, United States
Anthos Investigational site 9939
Birmingham, Alabama, United States
Anthos Investigative Site 9947
Birmingham, Alabama, United States
Anthos Investigative Site 1041
Mobile, Alabama, United States
Anthos Investigative Site 1089
Gilbert, Arizona, United States
Anthos Investigative Site 1099
Peoria, Arizona, United States
Anthos Investigative Site 9906
Phoenix, Arizona, United States
Anthos Investigative Site 9927
Yuma, Arizona, United States
Anthos Investigative Site 9929
Huntington Beach, California, United States
Anthos Investigative Site 9959
Imperial, California, United States
Anthos Investigative Site 9921
Lancaster, California, United States
Anthos Investigative Site 1078
Loma Linda, California, United States
Anthos Investigative Site 1077
Los Angeles, California, United States
Anthos Investigative Site 1015
Northridge, California, United States
Anthos Investigative Site 1070
Redding, California, United States
Anthos Investigative Site 1071
San Dimas, California, United States
Anthos Investigative Site 1076
Santa Ana, California, United States
Anthos Investigative Site 9938
Santa Rosa, California, United States
Anthos Investigative Site 9908
South Gate, California, United States
Anthos Investigative Site 9907
Vista, California, United States