Atrial Fibrillation (AF) Clinical Trial
— LILAC-TIMI 76Official title:
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)
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.
| Status | Recruiting |
| Enrollment | 1900 |
| Est. completion date | March 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | 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 Other protocol defined Inclusion/Exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Anthos Investigative Site 1518 | Aracaju | |
| Brazil | Anthos Investigative Site 1507 | Belo Horizonte | |
| Brazil | Anthos Investigative Site 1516 | Belo Horizonte | |
| Brazil | Anthos Investigative Site 1527 | Belo Horizonte | |
| Brazil | Anthos Investigative Site 1528 | Belo Horizonte | |
| Brazil | Anthos Investigative Site 1505 | Blumenau | |
| Brazil | Anthos Investigative Site 1513 | Blumenau | |
| Brazil | Anthos Investigative Site 1535 | Brasília | |
| Brazil | Anthos Investigative Site 1501 | Campina Grande Do Sul | |
| Brazil | Anthos Investigative Site 1503 | Campinas | |
| Brazil | Anthos Investigative Site 1522 | Campinas | |
| Brazil | Anthos Investigative Site 1520 | Campo Grande | |
| Brazil | Anthos Investigative Site 1532 | Canoas | |
| Brazil | Anthos Investigative Site 1526 | Caxias Do Sul | |
| Brazil | Anthos Investigative Site 1509 | Curitiba | |
| Brazil | Anthos Investigative Site 1540 | Curitiba | |
| Brazil | Anthos Investigative Site 1525 | Goiânia | |
| Brazil | Anthos Investigative Site 1502 | Marília | |
| Brazil | Anthos Investigative Site 1533 | Passo Fundo | |
| Brazil | Anthos Investigative Site 1506 | Porto Alegre | |
| Brazil | Anthos Investigative Site 1508 | Porto Alegre | |
| Brazil | Anthos Investigative Site 1517 | Porto Alegre | |
| Brazil | Anthos Investigative Site 1519 | Porto Alegre | |
| Brazil | Anthos Investigative Site 1524 | Porto Alegre | |
| Brazil | Anthos Investigative Site 1530 | Porto Alegre | |
| Brazil | Anthos Investigative Site 1531 | Recife | |
| Brazil | Anthos Investigative Site 1515 | Ribeirão Preto | |
| Brazil | Anthos Investigative Site 1536 | Ribeirão Preto | |
| Brazil | Anthos Investigative Site 1537 | Rio De Janeiro | |
| Brazil | Anthos Investigative Site 1510 | Salvador | |
| Brazil | Anthos Investigative Site 1521 | Salvador | |
| Brazil | Anthos Investigative Site 1529 | São Paulo | |
| Brazil | Anthos Investigative Site 1534 | São Paulo | |
| Brazil | Anthos Investigative Site 1538 | São Paulo | |
| Brazil | Anthos Investigative Site 1514 | Tatuí | |
| Brazil | Anthos Investigative Site 1504 | Votuporanga | |
| Bulgaria | Anthos Investigative Site 6014 | Blagoevgrad | |
| Bulgaria | Anthos Investigative Site 6026 | Burgas | |
| Bulgaria | Anthos Investigative Site 6019 | Gabrovo | |
| Bulgaria | Anthos Investigative Site 6018 | Haskovo | |
| Bulgaria | Anthos Investigative Site 6013 | Panagyurishte | |
| Bulgaria | Anthos Investigative Site 6025 | Pazardzhik | |
| Bulgaria | Anthos Investigative Site 6003 | Pleven | |
| Bulgaria | Anthos Investigative Site 6006 | Pleven | |
| Bulgaria | Anthos Investigative Site 6004 | Plovdiv | |
| Bulgaria | Anthos Investigative Site 6007 | Plovdiv | |
| Bulgaria | Anthos Investigative Site 6008 | Plovdiv | |
| Bulgaria | Anthos Investigative Site 6009 | Plovdiv | |
| Bulgaria | Anthos Investigative Site 6021 | Plovdiv | |
| Bulgaria | Anthos Investigative Site 6027 | Sliven | |
| Bulgaria | Anthos Investigative Site 6022 | Smolyan | |
| Bulgaria | Anthos Investigative Site 6001 | Sofia | |
| Bulgaria | Anthos Investigative Site 6002 | Sofia | |
| Bulgaria | Anthos Investigative Site 6010 | Sofia | |
| Bulgaria | Anthos Investigative Site 6012 | Sofia | |
| Bulgaria | Anthos Investigative Site 6015 | Sofia | |
| Bulgaria | Anthos Investigative Site 6017 | Sofia | |
| Bulgaria | Anthos Investigative Site 6020 | Sofia | |
| Bulgaria | Anthos Investigative Site 6023 | Sofia | |
| Bulgaria | Anthos Investigative Site 6024 | Sofia | |
| Bulgaria | Anthos Investigative Site 6028 | Sofia | |
| Bulgaria | Anthos Investigative Site 6011 | Stara Zagora | |
| Canada | Anthos Investigative Site 2016 | Abbotsford | |
| Canada | Anthos Investigative Site 2003 | Cambridge | Ontario |
| Canada | Anthos Investigative Site 2007 | Chicoutimi | Quebec |
| Canada | Anthos Investigative Site 2015 | Edmonton | |
| Canada | Anthos Investigative Site 2018 | Greenfield Park | |
| Canada | Anthos Investigative Site 2005 | Halifax | |
| Canada | Anthos Investigative Site 2012 | Mira Road | Nova Scotia |
| Canada | Anthos Investigative Site 2014 | Montréal | |
| Canada | Anthos Investigative Site 2004 | New Westminster | |
| Canada | Anthos Investigative Site 2021 | North Vancouver | |
| Canada | Anthos Investigative Site 2002 | Québec | |
| Canada | Anthos Investigative Site 2006 | Saint-Jérôme | |
| Canada | Anthos Investigative Site 2010 | Sherbrooke | Quebec |
| Canada | Anthos Investigative Site 2022 | Thunder Bay | |
| Chile | Anthos Investigative Site 1606 | Independencia | |
| Chile | Anthos Investigative Site 1604 | Providencia | |
| Chile | Anthos Investigative Site 1607 | San Bernardo | |
| Chile | Anthos Investigative Site 1609 | San Miguel | |
| Chile | Anthos Investigative Site 1608 | Santiago | |
| Chile | Anthos Investigative Site 1610 | Talcahuano | |
| Chile | Anthos Investigative Site 1602 | Temuco | |
| Chile | Anthos Investigative Site 1603 | Temuco | |
| Chile | Anthos Investigative Site 1601 | Viña Del Mar | |
| China | Anthos Investigative Site 1818 | Changchun | |
| China | Anthos Investigative Site 1810 | Changsha | |
| China | Anthos Investigative Site 1811 | Changsha | |
| China | Anthos Investigative Site 1802 | Chengdu | |
| China | Anthos Investigative Site 1809 | Haidian | |
| China | Anthos Investigative Site 1801 | Hangzhou | |
| China | Anthos Investigative Site 1808 | Hangzhou | |
| China | Anthos Investigative Site 1816 | Jinan | |
| China | Anthos Investigative Site 1804 | Lianyungang | |
| China | Anthos Investigative Site 1814 | Luoyang | |
| China | Anthos Investigative Site 1817 | Nanchang | |
| China | Anthos Investigative Site 1820 | Nanchang | |
| China | Anthos Investigative Site 1803 | Nanjing | |
| China | Anthos Investigative Site 1815 | Ningbo | |
| China | Anthos Investigative Site 1819 | Shijiazhuang | |
| China | Anthos Investigative Site 1812 | Tianjin | |
| China | Anthos Investigative Site 1813 | Yangzhou | |
| China | Anthos Investigative Site 1805 | Yinchuan | |
| Czechia | Anthos Investigative Site 3002 | Brandýs Nad Labem | |
| Czechia | Anthos Investigative Site 3006 | Liberec | |
| Czechia | Anthos Investigative Site 3007 | Ostrava - Poruba | |
| Czechia | Anthos Investigative Site 3001 | Podebrady | |
| Czechia | Anthos Investigative Site 3003 | Prague | |
| Czechia | Anthos Investigative Site 3004 | Praha | |
| Czechia | Anthos Investigative Site 3005 | Praha | |
| Czechia | Anthos Investigative Site 3010 | Praha | |
| Czechia | Anthos Investigative Site 3009 | Trutnov | |
| Czechia | Anthos Investigative Site 3011 | Ústí Nad Labem | |
| Estonia | Anthos Investigative Site 2201 | Tallinn | |
| Estonia | Anthos Investigative Site 2202 | Tallinn | |
| Germany | Anthos Investigative Site 7006 | Altenburg | |
| Germany | Anthos Investigative Site 7014 | Berlin | |
| Germany | Anthos Investigative Site 7004 | Dresden | |
| Germany | Anthos Investigative Site 7003 | Hamburg | |
| Germany | Anthos Investigative Site 7013 | Hannover | |
| Germany | Anthos Investigative Site 7009 | Ludwigshafen | |
| Germany | Anthos Investigative Site 7002 | Markkleeberg | |
| Germany | Anthos Investigative Site 7007 | Paderborn | |
| Germany | Anthos Investigative Site 7001 | Schwerin | |
| Hungary | Anthos Investigative Site 4002 | Békéscsaba | |
| Hungary | Anthos Investigative Site 4006 | Budapest | |
| Hungary | Anthos Investigative Site 4009 | Budapest | |
| Hungary | Anthos Investigative Site 4015 | Budapest | |
| Hungary | Anthos Investigative Site 4011 | Gyöngyös | |
| Hungary | Anthos Investigative Site 4012 | Kaposvar | |
| Hungary | Anthos Investigative Site 4007 | Kistarcsa | |
| Hungary | Anthos Investigative Site 4005 | Nyíregyháza | |
| Hungary | Anthos Investigative Site 4010 | Pécs | |
| Hungary | Anthos Investigative Site 4017 | Szeged | |
| Hungary | Anthos Investigative Site 4016 | Veszprém | |
| Hungary | Anthos Investigative Site 4008 | Zalaegerszeg | |
| India | Anthos Investigative Site 2310 | Ahmedabad | |
| India | Anthos Investigative Site 2311 | Bangalore | |
| India | Anthos Investigative Site 2318 | Bhubaneswar | |
| India | Anthos Investigative Site 2304 | Kochi | |
| India | Anthos Investigative Site 2314 | Kolkata | |
| India | Anthos Investigative Site 2315 | Nagpur | |
| India | Anthos Investigative Site 2316 | Nagpur | |
| India | Anthos Investigative Site 2307 | New Delhi | |
| India | Anthos Investigative Site 2317 | Pune | |
| India | Anthos Investigative Site 2309 | Secunderabad | |
| India | Anthos Investigative Site 2312 | Visakhapatnam | |
| Israel | Anthos Investigative Site 1210 | Afula | |
| Israel | Anthos Investigative Site 1205 | Ashkelon | |
| Israel | Anthos Investigative Site 1209 | H_olon | |
| Israel | Anthos Investigative Site 1206 | Hadera | |
| Israel | Anthos Investigative Site 1201 | Haifa | |
| Israel | Anthos Investigative Site 1211 | Haifa | |
| Israel | Anthos Investigative Site 1204 | Kfar Saba | |
| Israel | Anthos Investigative Site 1202 | Nahariya | |
| Israel | Anthos Investigative Site 1207 | Petah tikva | |
| Israel | Anthos Investigative Site 1203 | Re?ovot | |
| Israel | Anthos Investigative Site 1208 | Zefat | |
| Italy | Anthos Investigative Site 8003 | Bologna | |
| Italy | Anthos Investigative Site 8008 | Catanzaro | |
| Italy | Anthos Investigative Site 8013 | Lecco | |
| Italy | Anthos Investigative Site 8007 | Milan | |
| Italy | Anthos Investigative Site 8001 | Milano | |
| Italy | Anthos Investigative Site 8002 | Roma | |
| Italy | Anthos Investigative Site 8010 | Roma | |
| Italy | Anthos Investigative Site 8011 | Roma | |
| Italy | Anthos Investigative Site 8004 | Saronno | |
| Italy | Anthos Investigative Site 8005 | Sesto San Giovanni | |
| Italy | Anthos Investigative Site 8014 | Torino | |
| Italy | Anthos Investigative Site 8006 | Varese | |
| Italy | Anthos Investigative Site 8009 | Vittoria | |
| Japan | Anthos Investigative Site 1908 | Chikushino-shi | |
| Japan | Anthos Investigative Site 1902 | Chuo-Ku | |
| Japan | Anthos Investigative Site 1920 | Funabashi-Shi | |
| Japan | Anthos Investigative Site 1910 | Hamada-shi | |
| Japan | Anthos Investigative Site 1906 | Himeji-Shi | |
| Japan | Anthos Investigative Site 1911 | Imabari-shi | |
| Japan | Anthos Investigative Site 1912 | Isehara-Shi | |
| Japan | Anthos Investigative Site 1921 | Koto-Ku | |
| Japan | Anthos Investigative Site 1915 | Kure-shi | |
| Japan | Anthos Investigative Site 1903 | Matsumoto-Shi | |
| Japan | Anthos Investigative Site 1907 | Nagano-Shi | |
| Japan | Anthos Investigative Site 1922 | Sapporo-shi | |
| Japan | Anthos Investigative Site 1904 | Sendai-shi | |
| Japan | Anthos Investigative Site 1913 | Shimonoseki-shi | |
| Japan | Anthos Investigative Site 1914 | Tachikawa-shi | |
| Japan | Anthos Investigative Site 1909 | Tochigi | |
| Japan | Anthos Investigative Site 1901 | Urayasu | |
| Japan | Anthos Investigative Site 1917 | Uwajima-Shi | |
| Japan | Anthos Investigative Site 1916 | Yokohama-Shi | |
| Japan | Anthos Investigative Site 1918 | Yokohama-shi | |
| Japan | Anthos Investigative Site 1919 | Yokohama-Shi | |
| Latvia | Anthos Investigative Site 2103 | Baldone | |
| Latvia | Anthos Investigative Site 2109 | Balvi | |
| Latvia | Anthos Investigative Site 2107 | Daugavpils | |
| Latvia | Anthos Investigative Site 2108 | Limbazi | |
| Latvia | Anthos Investigative Site 2101 | Riga | |
| Latvia | Anthos Investigative Site 2102 | Riga | |
| Latvia | Anthos Investigative Site 2105 | Riga | |
| Latvia | Anthos Investigative Site 2110 | Riga | |
| Latvia | Anthos Investigative Site 2111 | Sigulda | |
| Latvia | Anthos Investigative Site 2104 | Valmiera | |
| Latvia | Anthos Investigative Site 2106 | Valmiera | |
| Mexico | Anthos Investigative Site 1701 | Aguascalientes | |
| Mexico | Anthos Investigative Site 1707 | Aguascalientes | |
| Mexico | Anthos Investigative Site 1713 | Aguascalientes | |
| Mexico | Anthos Investigative Site 1721 | Chihuahua | |
| Mexico | Anthos Investigative Site 1703 | Culiacán | |
| Mexico | Anthos Investigative Site 1704 | Monterrey | |
| Mexico | Anthos Investigative Site 1719 | Monterrey | |
| Mexico | Anthos Investigative Site 1702 | Querétaro | |
| Mexico | Anthos Investigative Site 1718 | San Luis Potosí | |
| Mexico | Anthos Investigative Site 1706 | Veracruz | |
| Mexico | Anthos Investigative Site 1708 | Veracruz | |
| Poland | Anthos Investigative Site 5022 | Czeladz | |
| Poland | Anthos Investigative Site 5003 | Katowice | |
| Poland | Anthos Investigative Site 5005 | Katowice | |
| Poland | Anthos Investigative Site 5009 | Katowice | |
| Poland | Anthos Investigative Site 5016 | Kraków | |
| Poland | Anthos Investigative Site 5018 | Kraków | |
| Poland | Anthos Investigative Site 5012 | Lódz | |
| Poland | Anthos Investigative Site 5028 | Lódz | |
| Poland | Anthos Investigative Site 5006 | Lublin | |
| Poland | Anthos Investigative Site 5023 | Lublin | |
| Poland | Anthos Investigative Site 5008 | Olsztyn | |
| Poland | Anthos Investigative Site 5025 | Oswiecim | |
| Poland | Anthos Investigative Site 5002 | Przemysl | |
| Poland | Anthos Investigative Site 5004 | Rzeszów | |
| Poland | Anthos Investigative Site 5001 | Tychy | |
| Poland | Anthos Investigative Site 5011 | Warszawa | |
| Poland | Anthos Investigative Site 5014 | Warszawa | |
| Poland | Anthos Investigative Site 5015 | Warszawa | |
| Poland | Anthos Investigative Site 5017 | Warszawa | |
| Poland | Anthos Investigative Site 5007 | Wroclaw | |
| Poland | Anthos Investigative Site 5019 | Wroclaw | |
| Romania | Anthos Investigative Site 9022 | Balotesti | |
| Romania | Anthos Investigative Site 9001 | Braila | |
| Romania | Anthos Investigative Site 9023 | Bucharest | |
| Romania | Anthos Investigative Site 9019 | Bucuresti | |
| Romania | Anthos Investigative Site 9024 | Cluj-Napoca | |
| Romania | Anthos Investigative Site 9006 | Craiova | |
| Romania | Anthos Investigative Site 9017 | Craiova | |
| Romania | Anthos Investigative Site 9010 | Oradea | |
| Romania | Anthos Investigative Site 9014 | Pitesti | |
| Romania | Anthos Investigative Site 9025 | Pitesti | |
| Romania | Anthos Investigative Site 9012 | Satu Mare | |
| Romania | Anthos Investigative Site 9003 | Târgu-Mures | |
| Romania | Anthos Investigative Site 9004 | Târgu-Mures | |
| Romania | Anthos Investigative Site 9016 | Târgu-Mures | |
| Romania | Anthos Investigative Site 9021 | Târgu-Mures | |
| Romania | Anthos Investigative Site 9005 | Timisoara | |
| Romania | Anthos Investigative Site 9007 | Timisoara | |
| Romania | Anthos Investigative Site 9008 | Timisoara | |
| Romania | Anthos Investigative Site 9013 | Timisoara | |
| Romania | Anthos Investigative Site 9018 | Timisoara | |
| Spain | Anthos Investigative Site 1108 | A Coruña | |
| Spain | Anthos Investigative Site 1116 | Almería | |
| Spain | Anthos Investigative Site 1109 | Cabra | |
| Spain | Anthos Investigative Site 1103 | Granada | |
| Spain | Anthos Investigative Site 1111 | Jaén | |
| Spain | Anthos Investigative Site 1118 | León | |
| Spain | Anthos Investigative Site 1104 | Madrid | |
| Spain | Anthos Investigative Site 1106 | Madrid | |
| Spain | Anthos Investigative Site 1113 | Madrid | |
| Spain | Anthos Investigative Site 1117 | Madrid | |
| Spain | Anthos Investigative Site 1105 | Málaga | |
| Spain | Anthos Investigative Site 1110 | Murcia | |
| Spain | Anthos Investigative Site 1115 | Oviedo | |
| Spain | Anthos Investigative Site 1107 | Santiago De Compostela | |
| Spain | Anthos Investigative Site 1102 | Sevilla | |
| Spain | Anthos Investigative Site 1112 | Terrassa | |
| Spain | Anthos Investigative Site 1101 | Valencia | |
| Spain | Anthos Investigative Site 1119 | Vigo | |
| United Kingdom | Anthos Investigative Site 1303 | Corby | |
| United Kingdom | Anthos Investigative Site 1315 | Hayle | |
| United Kingdom | Anthos Investigative Site 1311 | High Wycombe | |
| United Kingdom | Anthos Investigative Site 1301 | Isleworth | |
| United Kingdom | Anthos Investigative Site 1309 | Leeds | |
| United Kingdom | Anthos Investigative Site 1308 | London | |
| United Kingdom | Anthos Investigative Site 1314 | London | |
| United Kingdom | Anthos Investigative Site 1312 | Manchester | |
| United Kingdom | Anthos Investigative Site 1307 | Newcastle Upon Tyne | |
| United Kingdom | Anthos Investigative Site 1305 | Peterborough | |
| United Kingdom | Anthos Investigative Site 1302 | Stevenage | |
| United Kingdom | Anthos Investigative Site 1310 | Stockton-on-Tees | |
| United Kingdom | Anthos Investigative Site 1306 | Taunton | |
| United States | Anthos Investigative Site 1006 | Alexandria | Louisiana |
| United States | Anthos Investigative Site 1084 | American Fork | Utah |
| United States | Anthos Investigative Site 1039 | Baltimore | Maryland |
| United States | Anthos Investigative Site 1054 | Bangor | Maine |
| United States | Anthos Investigative Site 1040 | Birmingham | Alabama |
| United States | Anthos Investigative Site 1013 | Boca Raton | Florida |
| United States | Anthos Investigative Site 1082 | Boston | Massachusetts |
| United States | Anthos Investigative Site 1031 | Bountiful | Utah |
| United States | Anthos Investigative Site 1074 | Bristol | Pennsylvania |
| United States | Anthos Investigative Site 1065 | Cary | North Carolina |
| United States | Anthos Investigative Site 1005 | Charlotte | North Carolina |
| United States | Anthos Investigative Site 1022 | Clearwater | Florida |
| United States | Anthos Investigative Site 1025 | Clearwater | Florida |
| United States | Anthos Investigative Site 1019 | Daytona Beach | Florida |
| United States | Anthos Investigative Site 1049 | Denver | Colorado |
| United States | Anthos Investigative Site 1091 | El Paso | Texas |
| United States | Anthos Investigative Site 1050 | Elizabethton | Tennessee |
| United States | Anthos Investigative Site 1094 | Englewood | New Jersey |
| United States | Anthos Investigative Site 1018 | Falls Church | Virginia |
| United States | Anthos Investigative Site 1048 | Fayetteville | North Carolina |
| United States | Anthos Investigative Site 1057 | Germantown | Tennessee |
| United States | Anthos Investigative Site 1089 | Gilbert | Arizona |
| United States | Anthos Investigative Site 1035 | Henderson | North Carolina |
| United States | Anthos Investigative Site 1029 | Holladay | Utah |
| United States | Anthos Investigative Site 1083 | Hollywood | Florida |
| United States | Anthos Investigative Site 1087 | Horsham | Pennsylvania |
| United States | Anthos Investigative Site 1053 | Houston | Texas |
| United States | Anthos Investigative Site 1064 | Houston | Texas |
| United States | Anthos Investigative Site 1068 | Houston | Texas |
| United States | Anthos Investigative Site 1069 | Houston | Texas |
| United States | Anthos Investigative Site 1008 | Jacksonville | Florida |
| United States | Anthos Investigative Site 1080 | Kansas City | Missouri |
| United States | Anthos Investigative Site 1023 | Lanham | Maryland |
| United States | Anthos Investigative Site 1021 | Lansing | Michigan |
| United States | Anthos Investigative Site 1036 | Las Vegas | Nevada |
| United States | Anthos Investigative Site 1001 | Lenoir | North Carolina |
| United States | Anthos Investigative Site 1066 | Lincoln | Nebraska |
| United States | Anthos Investigative Site 1052 | Lithonia | Georgia |
| United States | Anthos Investigative Site 1078 | Loma Linda | California |
| United States | Anthos Investigative Site 1077 | Los Angeles | California |
| United States | Anthos Investigative Site 1093 | Lutz | Florida |
| United States | Anthos Investigative Site 1033 | Macon | Georgia |
| United States | Anthos Investigative Site 1010 | Manassas | Virginia |
| United States | Anthos Investigative Site 1063 | McAllen | Texas |
| United States | Anthos Investigative Site 1079 | McKinney | Texas |
| United States | Anthos Investigative Site 1056 | Memphis | Tennessee |
| United States | Anthos Investigative Site 1072 | Miami Lakes | Florida |
| United States | Anthos Investigative Site 1014 | Middletown | New York |
| United States | Anthos Investigative Site 1041 | Mobile | Alabama |
| United States | Anthos Investigative Site 1042 | Norcross | Georgia |
| United States | Anthos Investigative Site 1015 | Northridge | California |
| United States | Anthos Investigative Site 1024 | Odessa | Texas |
| United States | Anthos Investigative Site 1067 | Ormond Beach | Florida |
| United States | Anthos Investigative Site 1030 | Park Ridge | Illinois |
| United States | Anthos Investigative Site 1038 | Pleasant View | Utah |
| United States | Anthos Investigative Site 1085 | Port Arthur | Texas |
| United States | Anthos Investigative Site 1070 | Redding | California |
| United States | Anthos Investigative Site 1009 | Roanoke | Virginia |
| United States | Anthos Investigative Site 1032 | Rock Hill | South Carolina |
| United States | Anthos Investigative Site 1028 | Rockville | Maryland |
| United States | Anthos Investigative Site 1037 | Rosedale | New York |
| United States | Anthos Investigative Site 1034 | Roy | Utah |
| United States | Anthos Investigative Site 1026 | Safety Harbor | Florida |
| United States | Anthos Investigative Site 1002 | Saint Augustine | Florida |
| United States | Anthos Investigative Site 1004 | Saint Augustine | Florida |
| United States | Anthos Investigative Site 1071 | San Dimas | California |
| United States | Anthos Investigative Site 1076 | Santa Ana | California |
| United States | Anthos Investigative Site 1043 | Shreveport | Louisiana |
| United States | Anthos Investigative Site 1059 | Southgate | Michigan |
| United States | Anthos Investigative Site 1012 | Stamford | Connecticut |
| United States | Anthos Investigative Site 1090 | Sugar Land | Texas |
| United States | Anthos Investigative Site 1003 | Suwanee | Georgia |
| United States | Anthos Investigative Site 1073 | Tacoma | Washington |
| United States | Anthos Investigative Site 1044 | Tamarac | Florida |
| United States | Anthos Investigative Site 1088 | Tamarac | Florida |
| United States | Anthos Investigative Site 1046 | Tampa | Florida |
| United States | Anthos Investigative Site 1011 | Tomball | Texas |
| United States | Anthos Investigative Site 1017 | Tupelo | Mississippi |
| United States | Anthos Investigative Site 1060 | Waco | Texas |
| United States | Anthos Investigative Site 1016 | Wichita | Kansas |
| United States | Anthos Investigative Site 1092 | Wylie | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Anthos Therapeutics, Inc. |
United States, Brazil, Bulgaria, Canada, Chile, China, Czechia, Estonia, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Mexico, Poland, Romania, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy: Time to first event of ischemic stroke or systemic embolism (SE) | Up to 30 months | ||
| Primary | Safety: Time to first occurrence of Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding | Up to 30 months | ||
| Secondary | 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 | Up to 30 months | |
| Secondary | Efficacy: Time to first event of ischemic stroke, systemic embolism (SE), or Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding event | Up to 30 months | ||
| Secondary | Efficacy: Cardiovascular (CV) mortality | Up to 30 months | ||
| Secondary | Efficacy: All-cause mortality | Up to 30 months | ||
| Secondary | 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 | Up to 30 months |
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