Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Participants must be ≥ 18 years of age
- Acute non-cardioembolic stroke or high-risk TIA
- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Exclusion Criteria:
- Recent ischemic stroke within 7 days before index event
- Strokes (index event) following procedures (e.g. TAVI, CABG) or strokes due to other rare causes (e.g. bacterial endocarditis, vertebral artery dissections)
- Known premorbid (before index event) mRS ≥ 4
- History of atrial fibrillation / flutter, left ventricular thrombus, mechanical valve or other cardioembolic source of stroke requiring anticoagulation
- Sustained uncontrolled hypertension after index stroke/TIA event
- Known vascular malformation of the brain with high risk for bleeding (except isolated cavernoma, aneurysm treated and secured, or aneurysm with diameter < 5 mm)
- Active non-trivial bleeding (including PH1 or PH2 hemorrhagic transformation of the index stroke event, if known before randomization4 ); known chronic bleeding disorder (e.g., von Willebrand disease); history of non-traumatic intracranial hemorrhage (does not include cerebral microbleeds or asymptomatic hemorrhagic transformation of an ischemic stroke); other non-traumatic major bleeding or clinically significant gastrointestinal bleeding within last 6 months before randomization
- Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis, or signs of coagulopathy) or known hepatic insufficiency classified as Child-Pugh B or C at randomization
- End stage renal disease requiring dialysis or expected to be started on dialysis within the next 12 months
- Major surgery during the last 30 days prior to randomization
- Known allergy, intolerance or hypersensitivity to the study intervention (asundexian or excipients)Concomitant use, planned use or anticipated need for
• Oral anticoagulation;
• Full dose and/or long-term anticoagulation therapy with heparin/LMWH during study conduct;
• Chronic (more than 4 weeks continuous) therapy with NSAIDs during the study conduct;
• Concomitant use of combined P-gp and strong CYP3A4 inducers; e.g. carbamazepine, St John’s wort7 , as well as within 14 days (or at least five half-lives of the active substance, whichever is longer) before randomization;
• Concomitant use of combined P-gp and strong CYP3A4 inhibitors e.g. human immunodeficiency virus protease inhibitors, systemically used azole antimycotic agents (e.g., ketoconazole), clarithromycin, nefazodone, as well as within 14 days (or at least five half-lives of the active substance, whichever is longer) before randomization;
• Herbal or traditional medicine, and / or supplements with known anticoagulant and / or antiplatelet effect (a list of the most commonly used ones will be provided separately).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/17/24. Questions regarding updates should be directed to the study team contact.