A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA
A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had:
Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting).
The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding.
The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health.
Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months.
Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned.
During the study, the study team will:
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90027, United States
Newport Beach, California 92663, United States
Santa Barbara, California 93105, United States
New Haven, Connecticut 06519, United States
Newark, Delaware 19718, United States
Clearwater, Florida 33756, United States
Tampa, Florida 33606, United States
Tampa, Florida 33607, United States
Rockford, Illinois 61114, United States
Baltimore, Maryland 21201, United States
Pontiac, Michigan 48341, United States
Buffalo, New York 14220, United States
New York, New York 10032, United States
Winston-Salem, North Carolina 27157, United States
Dayton, Ohio 45409, United States
Toledo, Ohio 43606, United States
Erie, Pennsylvania 16507, United States
Philadelphia, Pennsylvania 19104, United States
Philadelphia, Pennsylvania 19140, United States
Greenville, South Carolina 29605, United States
Knoxville, Tennessee 37920, United States
Fort Worth, Texas 76104, United States
San Antonio, Texas 78229, United States
Buenos Aires (Capital Federal), Buenos Aires C1221 ADC, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Aires C1430BKC, Argentina
Mar del Plata, Buenos Aires B7602CBM, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires C1039AAO, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires C1428 AQK, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires C1437JCP, Argentina
Ciudad Autonoma de Buenos Aire, Ciudad Auton. de Buenos Aires C1199ABB, Argentina
Rosario, Santa Fe Province S2000GAP, Argentina
Liverpool, New South Wales 2170, Australia
Linz, Upper Austria 4020, Austria
Bruxelles - Brussel, 1200, Belgium
Ostend, 8400, Belgium
Espirito Santo, Espírito Santo 29018-140, Brazil
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
São José do Rio Preto, São Paulo 15090, Brazil
Dupnitsa, 2600, Bulgaria
Haskovo, 6300, Bulgaria
Pleven, 5800, Bulgaria
Pleven, 5800, Bulgaria
Plovdiv, 4000, Bulgaria
Plovdiv, 4002, Bulgaria
Rousse, 7002, Bulgaria
Sofia, 1000, Bulgaria
Sofia, 1202, Bulgaria
Sofia, 1309, Bulgaria
Sofia, 1407, Bulgaria
Sofia, 1527, Bulgaria
Sofia, 1606, Bulgaria
Sofia, 1797, Bulgaria
Sofia, 1797, Bulgaria
Calgary, Alberta T2N 2T9, Canada
Ottawa, Ontario K1Y4E9, Canada
JiangSu, Jiangsu 212001, China
Taian, Shandong 271099, China
Baranquilla, Atlántico 080020, Colombia
Floridablabca, 681011, Colombia
Ostrava - Poruba, 708 52, Czechia
Ostrava - Vitkovice, 703 00, Czechia
Praha 5-Motol, 150 00, Czechia
Ústí nad Labem, 401 13, Czechia
Dijon, 21079, France
Ampelokipoi Athens, 11526, Greece
Efkarpia, 56429, Greece
Thessaloniki, 546 36, Greece
Thessaloniki, 54636, Greece
Thessaloniki, 57010, Greece
Szeged, 6725, Hungary
Thiruvananthapuram, Kerala 695011, India
Petah Tikva, 4941492, Israel
Avezzano, Abruzzo 67051, Italy
Naples, Campania 80131, Italy
Salerno, Campania 84131, Italy
Bologna, Emilia-Romagna 40133, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Rome, Lazio 00133, Italy
Rome, Lazio 00168, Italy
Pietra Ligure, Liguria 17027, Italy
Palermo, Sicily 90146, Italy
Perugia, Umbria 06129, Italy
Verona, Veneto 37126, Italy
Torino, 10154, Italy
Aki-gun, Hiroshima 735-8585, Japan
Marugame, Kagawa-ken 763-8502, Japan
Kawasaki-shi, Kanagawa 211-8533, Japan
Nakano, Nagano 383-8505, Japan
Meguro-ku, Tokyo 152-8902, Japan
Meguro-ku, Tokyo 153-0051, Japan
Sumida-ku, Tokyo 130-8575, Japan
Okayama, 7008557, Japan
Kelantan, 15200, Malaysia
Kelantan, 16150, Malaysia
Sarawak, 93400, Malaysia
Terengganu, 20400, Malaysia
Nieuwegein, 3435 CM, Netherlands
Utrecht, 3584 CX, Netherlands
Lørenskog, 1478, Norway
Grodzisk Mazowiecki, 05-825, Poland
Katowice, 40-635, Poland
Amadora, Lisbon District 2720-276, Portugal
Matosinhos Municipality, Porto District 4464-513, Portugal
Almada, Setúbal District 2805-267, Portugal
Coimbra, 3004-561, Portugal
Faro, 8000-386, Portugal
Lisbon, 1749-004, Portugal
Porto, 4200-319, Portugal
Vranou Nad Toplou, 09327, Slovakia
Seoul, Seoul Teugbyeolsi 03722, South Korea
Seoul, Seoul Teugbyeolsi 05505, South Korea
Dong-gu, Gwangju, 61469, South Korea
A Coruña, A Coruña 15006, Spain
Santiago de Compostela, A Coruña 15706, Spain
Babio - Beade, Pontevedra 36312, Spain
Barakaldo, Vizcaya 48903, Spain
Barcelona, 08025, Spain
Lleida, 25198, Spain
Madrid, 28041, Spain
Madrid, 28046, Spain
Murcia, 30120, Spain
Canterbury, Kent CT1 3NG, United Kingdom
Kogarah, London 2217, United Kingdom
Salford, Manchester M6 8HD, United Kingdom
Newcastle upon Tyne, Tyne and Wear NE1 4LP, United Kingdom
Sunderland, Tyne and Wear SR4 7TP, United Kingdom
Leeds, West Yorkshire LS1 3EX, United Kingdom
Derby, DE22 3NE, United Kingdom
Exeter, EX2 5DW, United Kingdom
Glasgow, G31 2ER, United Kingdom
Liverpool, L9 7AL, United Kingdom
London, SE5 8AF, United Kingdom