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)
Launched by ANTHOS THERAPEUTICS, INC. · Jan 25, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The LILAC-TIMI 76 clinical trial is investigating the safety and effectiveness of a drug called abelacimab for patients with Atrial Fibrillation (AF) who are at high risk for blood clots but cannot take traditional blood thinners. This study aims to see if abelacimab can help reduce the chances of serious events like strokes or blood clots in patients who have been advised by their doctors or have chosen not to use oral anticoagulation therapy due to safety concerns.
To participate in the trial, patients must be between 65 and 74 years old with certain risk factors or 75 years and older with fewer risk factors. They also need to have a confirmed diagnosis of AF and be considered unsuitable for blood thinner medications or specific heart procedures. Participants will be monitored closely throughout the study to understand how well the medication works and to ensure their safety. If you or a loved one is considering joining the trial, it’s important to discuss it with your healthcare provider to see if it’s a good fit for you.
Gender
ALL
Eligibility criteria
- 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
About Anthos Therapeutics, Inc.
Anthos Therapeutics, Inc. is a biotechnology company dedicated to advancing innovative therapies for patients with cardiovascular and metabolic diseases. Leveraging cutting-edge science and a robust pipeline of novel drug candidates, Anthos focuses on addressing unmet medical needs through precision medicine and targeted treatments. The company is committed to rigorous clinical research and collaboration with healthcare professionals to ensure the development of safe and effective therapies that enhance patient outcomes and improve quality of life. With a strong emphasis on scientific integrity and patient-centered care, Anthos Therapeutics aims to make a meaningful impact in the field of therapeutic innovation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Johns Creek, Georgia, United States
Charlotte, North Carolina, United States
Lenoir, North Carolina, United States
Mobile, Alabama, United States
Stamford, Connecticut, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Safety Harbor, Florida, United States
Saint Augustine, Florida, United States
Saint Augustine, Florida, United States
Macon, Georgia, United States
Suwanee, Georgia, United States
Alexandria, Louisiana, United States
Lanham, Maryland, United States
Charlotte, North Carolina, United States
Lenoir, North Carolina, United States
Odessa, Texas, United States
Tomball, Texas, United States
Manassas, Virginia, United States
Northridge, California, United States
Norcross, Georgia, United States
Shreveport, Louisiana, United States
Rockville, Maryland, United States
Las Vegas, Nevada, United States
Henderson, North Carolina, United States
Elizabethton, Tennessee, United States
Bountiful, Utah, United States
Holladay, Utah, United States
Pleasant View, Utah, United States
Roy, Utah, United States
Falls Church, Virginia, United States
Roanoke, Virginia, United States
Stamford, Connecticut, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Safety Harbor, Florida, United States
Macon, Georgia, United States
Wichita, Kansas, United States
Alexandria, Louisiana, United States
Lansing, Michigan, United States
Manassas, Virginia, United States
Kfar Saba, , Israel
Petah Tikva, , Israel
Middletown, New York, United States
Rosedale, New York, United States
Rock Hill, South Carolina, United States
Houston, Texas, United States
Cambridge, Ontario, Canada
Haifa, , Israel
Birmingham, Alabama, United States
Redding, California, United States
Denver, Colorado, United States
Miami Lakes, Florida, United States
Ormond Beach, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Lithonia, Georgia, United States
Park Ridge, Illinois, United States
Baltimore, Maryland, United States
Southgate, Michigan, United States
Fayetteville, North Carolina, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Mcallen, Texas, United States
Halifax, , Canada
New Westminster, , Canada
Québec, , Canada
Saint Jérôme, , Canada
Ashkelon, , Israel
H̱olon, , Israel
Nahariya, , Israel
Reẖovot, , Israel
Chikushino Shi, , Japan
Chuo Ku, , Japan
Imabari Shi, , Japan
Nagano Shi, , Japan
Tochigi, , Japan
Urayasu, , Japan
Hamada Shi, , Japan
Isehara Shi, , Japan
Kure Shi, , Japan
Shimonoseki Shi, , Japan
Tachikawa Shi, , Japan
Germantown, Tennessee, United States
Mira Road, Nova Scotia, Canada
Zefat, , Israel
Himeji Shi, , Japan
Matsumoto Shi, , Japan
Uwajima Shi, , Japan
Yokohama Shi, , Japan
Kansas City, Missouri, United States
Lincoln, Nebraska, United States
Houston, Texas, United States
Houston, Texas, United States
Waco, Texas, United States
Funabashi Shi, , Japan
Sapporo Shi, , Japan
Yokohama Shi, , Japan
Los Angeles, California, United States
San Dimas, California, United States
Cary, North Carolina, United States
American Fork, Utah, United States
Hangzhou, , China
Koto Ku, , Japan
Sendai Shi, , Japan
Yokohama Shi, , Japan
Bangor, Maine, United States
Tacoma, Washington, United States
Boston, Massachusetts, United States
Mckinney, Texas, United States
Port Arthur, Texas, United States
Campina Grande Do Sul, , Brazil
Campinas, , Brazil
São Paulo, , Brazil
Sherbrooke, Quebec, Canada
Hollywood, Florida, United States
Marília, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Chicoutimi, Quebec, Canada
Viña Del Mar, , Chile
Chengdu, , China
Haidian, , China
Lianyungang, , China
Nanchang, , China
Yangzhou, , China
Corby, , United Kingdom
Isleworth, , United Kingdom
Stockton On Tees, , United Kingdom
Santa Ana, California, United States
Aracaju, , Brazil
Belo Horizonte, , Brazil
Blumenau, , Brazil
Canoas, , Brazil
Caxias Do Sul, , Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Votuporanga, , Brazil
Gabrovo, , Bulgaria
Panagyurishte, , Bulgaria
Pleven, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Independencia, , Chile
Ningbo, , China
Berlin, , Germany
Hamburg, , Germany
Schwerin, , Germany
Budapest, , Hungary
Békéscsaba, , Hungary
Nyíregyháza, , Hungary
Milan, , Italy
Czeladź, , Poland
Przemyśl, , Poland
Rzeszów, , Poland
Craiova, , Romania
Piteşti, , Romania
Satu Mare, , Romania
Târgu Mureş, , Romania
Târgu Mureş, , Romania
Málaga, , Spain
London, , United Kingdom
Taunton, , United Kingdom
Belo Horizonte, , Brazil
Campinas, , Brazil
Passo Fundo, , Brazil
Salvador, , Brazil
Blagoevgrad, , Bulgaria
Burgas, , Bulgaria
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Smolyan, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Santiago, , Chile
Brandýs Nad Labem, , Czechia
Liberec, , Czechia
Ostrava Poruba, , Czechia
Trutnov, , Czechia
Altenburg, , Germany
Paderborn, , Germany
Budapest, , Hungary
Kaposvar, , Hungary
Pécs, , Hungary
Zalaegerszeg, , Hungary
Hadera, , Israel
Milano, , Italy
Roma, , Italy
Sesto San Giovanni, , Italy
Katowice, , Poland
Katowice, , Poland
Kraków, , Poland
Lublin, , Poland
Olsztyn, , Poland
Oświęcim, , Poland
Tychy, , Poland
Warszawa, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wrocław, , Poland
Brăila, , Romania
Bucuresti, , Romania
Timişoara, , Romania
Timişoara, , Romania
Timişoara, , Romania
Timişoara, , Romania
Cabra, , Spain
Madrid, , Spain
Santiago De Compostela, , Spain
Sevilla, , Spain
Valencia, , Spain
Peterborough, , United Kingdom
Blumenau, , Brazil
Campo Grande, , Brazil
Ribeirão Preto, , Brazil
Pazardzhik, , Bulgaria
Montréal, , Canada
Nanchang, , China
Poděbrady, , Czechia
Markkleeberg, , Germany
Budapest, , Hungary
Gyöngyös, , Hungary
Szeged, , Hungary
Veszprém, , Hungary
Afula, , Israel
Roma, , Italy
Kraków, , Poland
Lublin, , Poland
Baloteşti, , Romania
Cluj Napoca, , Romania
Târgu Mureş, , Romania
Granada, , Spain
Jaén, , Spain
Madrid, , Spain
Newcastle Upon Tyne, , United Kingdom
Tupelo, Mississippi, United States
Luoyang, , China
Nanjing, , China
Tianjin, , China
Yinchuan, , China
Dresden, , Germany
Hannover, , Germany
Roma, , Italy
Saronno, , Italy
Warszawa, , Poland
łódź, , Poland
Bucharest, , Romania
Oradea, , Romania
Piteşti, , Romania
Murcia, , Spain
Terrassa, , Spain
High Wycombe, , United Kingdom
Bristol, Pennsylvania, United States
Belo Horizonte, , Brazil
Belo Horizonte, , Brazil
Brasília, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
San Bernardo, , Chile
Temuco, , Chile
Changchun, , China
Changsha, , China
Hangzhou, , China
Jinan, , China
Bologna, , Italy
Varese, , Italy
Wrocław, , Poland
Craiova, , Romania
Târgu Mureş, , Romania
Curitiba, , Brazil
San Miguel, , Chile
Changsha, , China
Shijiazhuang, , China
Praha, , Czechia
Timişoara, , Romania
A Coruña, , Spain
Madrid, , Spain
Stevenage, , United Kingdom
Gilbert, Arizona, United States
Horsham, Pennsylvania, United States
Sugar Land, Texas, United States
Wylie, Texas, United States
Tatuí, , Brazil
Sofia, , Bulgaria
Providencia, , Chile
Praha, , Czechia
Kistarcsa, , Hungary
Catanzaro, , Italy
Katowice, , Poland
Almería, , Spain
Vigo, , Spain
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Tamarac, Florida, United States
El Paso, Texas, United States
Sofia, , Bulgaria
Temuco, , Chile
Vittoria, , Italy
Riga, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Valmiera, , Latvia
Porto Alegre, , Brazil
Salvador, , Brazil
North Vancouver, , Canada
Prague, , Czechia
Daugavpils, , Latvia
Limbazi, , Latvia
Aguascalientes, , Mexico
Aguascalientes, , Mexico
Querétaro, , Mexico
León, , Spain
Madrid, , Spain
Abbotsford, , Canada
Thunder Bay, , Canada
Talcahuano, , Chile
Praha, , Czechia
Riga, , Latvia
Riga, , Latvia
Sigulda, , Latvia
Culiacán, , Mexico
Monterrey, , Mexico
San Luis Potosí, , Mexico
Veracruz, , Mexico
Oviedo, , Spain
Lutz, Florida, United States
São Paulo, , Brazil
Edmonton, , Canada
Haifa, , Israel
Torino, , Italy
Balvi, , Latvia
Chihuahua, , Mexico
Loma Linda, California, United States
Recife, , Brazil
Ribeirão Preto, , Brazil
Ahmedabad, , India
Kolkata, , India
Nagpur, , India
Nagpur, , India
Pune, , India
Secunderabad, , India
Visakhapatnam, , India
Baldone, , Latvia
Aguascalientes, , Mexico
Veracruz, , Mexico
łódź, , Poland
Hayle, , United Kingdom
Greenfield Park, , Canada
ústí Nad Labem, , Czechia
Ludwigshafen, , Germany
Kochi, , India
New Delhi, , India
Tallinn, , Estonia
Tallinn, , Estonia
Bangalore, , India
Lecco, , Italy
Monterrey, , Mexico
Englewood, New Jersey, United States
São Paulo, , Brazil
Bhubaneswar, , India
Merrillville, Indiana, United States
São Paulo, , Brazil
São Paulo, , Brazil
Teresina, , Brazil
Brampton, , Canada
Tallinn, , Estonia
Ahmedabad, , India
Jaipur, , India
Mumbai, , India
New Delhi, , India
Pune, , India
Visakhapatnam, , India
Guerrero, , Mexico
Monterrey, , Mexico
Tlalpan, , Mexico
Xalapa, , Mexico
Barcelona, , Spain
Barcelona, , Spain
King's Lynn, , United Kingdom
Beavercreek, Ohio, United States
Laredo, Texas, United States
Chandigarh, , India
Mckinney, Texas, United States
Concepción, , Chile
Houston, Texas, United States
Ghaziabad, , India
Ciudad De México, , Mexico
Phoenix, Arizona, United States
Houston, Texas, United States
Porto Alegre, , Brazil
Hamburg, , Germany
Brescia, , Italy
Guadalajara, , Mexico
Peoria, Arizona, United States
Lake Mary, Florida, United States
Kansa City, Missouri, United States
Ciudad Autónoma Buenos Aires, , Argentina
New Delhi, , India
Ancona, , Italy
Sevilla, , Spain
Glasgow, , United Kingdom
Aurora, Colorado, United States
Portland, Oregon, United States
Toronto, , Canada
Caserta, , Italy
Brooklyn, New York, United States
Palermo, , Italy
Bellville, , South Africa
Benoni, , South Africa
Pretoria, , South Africa
Vista, California, United States
Beaumont, Texas, United States
San Miguel De Tucumán, , Argentina
Tongaat, , South Africa
The Villages, Florida, United States
Webster, Texas, United States
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aire, , Argentina
Chennai, , India
Meerut, , India
Centurion, , South Africa
South Gate, California, United States
Durham, North Carolina, United States
Saint Catharines, , Canada
Chennai, , India
Dehradun, , India
Legnica, , Poland
Norwich, , United Kingdom
Stoke On Trent, , United Kingdom
S. Gate, California, United States
Evansville, Indiana, United States
Corrientes, , Argentina
San Luis, , Argentina
Las Vegas, Nevada, United States
Victoria, Texas, United States
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Colatina, , Brazil
Akashi, , Japan
Tyler, Texas, United States
Córdoba, , Argentina
Toronto, , Canada
Mangaluru, , India
Hamamatsu, , Japan
Córdoba, , Argentina
Córdoba, , Argentina
Salta, , Argentina
Cinisello Balsamo, , Italy
ōmihachiman, , Japan
Katowice, , Poland
Durban, , South Africa
Pretoria, , South Africa
Somerset West, , South Africa
Ciudad Autónoma De Buenos Aire, , Argentina
Córdoba, , Argentina
Matsue, , Japan
Naha, , Japan
Tokushima, , Japan
Zabrze, , Poland
Cape Town, , South Africa
Johannesburg, , South Africa
San Miguel De Tucumán, , Argentina
Toyama, , Japan
Tōon, , Japan
Gdynia, , Poland
London, , United Kingdom
Westfield, New York, United States
Coronel Suárez, , Argentina
Ramos Mejia, , Argentina
Sofia, , Bulgaria
Toronto, , Canada
Pisa, , Italy
Sabadell, , Spain
Yuma, Arizona, United States
Huntington Beach, California, United States
Lancaster, California, United States
Miami, Florida, United States
Winfield, Illinois, United States
Albany, New York, United States
Allen, Texas, United States
Greenville, Texas, United States
Buenos Aires, , Argentina
Quilmes, , Argentina
San Nicolas, , Argentina
Haskovo, , Bulgaria
Hamilton, , Canada
Krapinske Toplice, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Ajmer, , India
Jaipur, , India
Jerusalem, , Israel
Firenze, , Italy
Naples, , Italy
Napoli, , Italy
Osaka, , Japan
Tokyo, , Japan
Elbląg, , Poland
Gdynia, , Poland
Braşov, , Romania
Belgrade, , Serbia
Belgrade, , Serbia
Užice, , Serbia
Zaječar, , Serbia
Bardejov, , Slovakia
Lučenec, , Slovakia
Piešťany, , Slovakia
žilina, , Slovakia
Stockholm, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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