CATIS-ICAS is a double-blind, randomized, placebo-controlled (RCT), phase III study seeking to demonstrate that oral rivaroxaban 2.5 mg twice daily plus aspirin daily is superior to clopidogrel 75 mg daily plus aspirin daily for 90 days followed by placebo plus aspirin daily for preventing recurrent stroke in those with ischemic stroke secondary to intracranial atherosclerotic disease (ICAD) of 30-99%, when started within 30 days of index stroke.
Age > 40 years
Ischemic stroke or high-risk TIA (motor and/ or speech involvement)
Randomization within 30 days of index stroke
Stroke potentially attributable to ICAS 30-99% (or flow gap on time-offlight MRA) of a major intracranial artery (internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, intracranial vertebral artery, or basilar artery) by MRA or CTA or catheter angiography.
Cardioembolic stroke
Indication for long-term dual antiplatelet or anticoagulant therapy (e.g. venous thromboembolism, coronary stent, mechanical prosthetic valve)
Intracranial arterial stenosis secondary to causes other than atherosclerosis e.g. dissection, moya moya disease
Substantial extracranial carotid artery disease ipsilateral to the qualifying stroke with plans for carotid revascularization
Parallel
Rivaroxaban
DrugLow-dose rivaroxaban (2.5 mg BID) plus clinical ASA
ASA
Drugclopidogrel loading dose (if applicable), then dual antiplatelet therapy (placebo plus clopidogrel plus clinical ASA) for first 90 days, followed by placebo plus clinical ASA for remainder of treatment period.
Time to first symptomatic stroke for participants
Time to first symptomatic stroke (including ischemic, hemorrhagic and undefined) for all participants affected, by treatment arm
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