Health Condition 1: I67- Other cerebrovascular diseases
Conditions
Interventions
Intervention1: Milvexian: Participants after an acute ischemic stroke or high-risk transient ischemic attack (TIA) who are receiving antiplatelet therapy standard-of-care (SAPT [single antiplatelet th
Sponsors
Janssen Research & Development, LLC
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Ischemic Stroke: a neurological deficit attributable to an acute brain infarction and NIHSS score 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. • 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 protocol.
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of ischemic strokeTimepoint: Up to global targeted endpoint date (approximately 41 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke Time to First Occurrence of Ischemic Stroke Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE) Timepoint: Up to global targeted endpoint date (approximately 41 months) Up to Day 90 Up to global targeted endpoint date (approximately 41 months) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Republic of Korea, Romania, Serbia, Singapore, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States of America
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed