A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study toDemonstrate the Efficacy & Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Janssen Research & Development, LLC0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

研究概览

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•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,
•Acute, ischemic brain lesion determined by standard-of-care neuroimaging
•Participant underwent thrombolysis or thrombectomy
•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.
•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 agree not to be pregnant, breastfeeding, or planning to
•become pregnant until 4 days (5 half lives) after the last dose of study intervention
•Willing and able to adhere to the lifestyle restrictions (Section 5.3) specified in this

•Prior history of intracranial hemorrhage except subarachnoid hemorrhage > 1 year prior
•with adequate treatment.
•The index stroke or TIA is considered to have a cardio-embolic etiology based on local
•standard-of-care investigations and for which guidelines recommend anticoagulation.
•The index stroke or TIA considered to have an other known cause, not related to athero
•thrombotic sources (TOAST Other Determined Etiology) (Adams 1993), based on local standard-of-care investigations.
•Conditions with an increased risk of bleeding, including:
•Clinically significant bleeding within the previous 3 months
•Known bleeding diathesis
•Known aPTT prolongation > 1.4 times the ULN or known congenital FXI deficiency
•Spinal cord hemorrhage
•Retinal hemorrhage
•Current active liver disease, eg, acute hepatitis, known cirrhosis, including participants
•receiving antiviral treatment for hepatitis.
•Known allergies, hypersensitivity, or intolerance to milvexian or its excipients (refer to the
•milvexian IB).

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