A Phase 3 Placebo-controlled Study of Milvexian after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

You may be able to join if

• Age ≥40 years of age
• Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and NIHSS score ≤ 7 and at least 1 of the following: Persistent signs or symptoms of the ischemic event at the time of randomization, OR Acute, ischemic brain lesion determined by standard-of-care neuroimaging OR Participant underwent thrombolysis or thrombectomy OR TIA: acute onset neurological deficit attributable to focal ischemia of the brain by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (eg, CT scan or MRI, performed as part of standard medical practice), and ABCD2 Score ≥6
• Participants will be randomized as soon as possible after determining eligibility and within 48 hours of onset of event. In participants in whom a stroke was evident on awakening from sleep, within 48 hours from the time at which the participants’ condition was last reported to be normal. Participants who received thrombolysis and/or mechanical thrombectomy with or without stenting can be randomized but only after 24 hours have elapsed after the end of this treatment and not more than 48 hours after the onset of the index event, and provided that post-treatment neuroimaging excludes cerebral bleeding and have postthrombolytic therapy/post-thrombectomy INR ≤ 1.5 and aPTT ≤ 1.4 times the ULN prior to study randomization. Cerebrovascular vessel stenting is allowed as clinically indicated. If these procedures are done pre-randomization, then randomization should occur at least 24 hours after the end of the procedure and not more than 48 hours after the onset of the index event.
• Current or planned antiplatelet treatment per international and/or local guidelines. If ASA is used, it will be limited to low dose (75 to 100 mg/day). Loading dose of antiplatelet agents (including ASA) are allowed per standard-of-care
• A female participant must be a. Not of childbearing potential or b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agrees to remain on a highly effective method until 4 days (5 half lives) after last dose of study intervention –the end of relevant exposure. The investigator must evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.