Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial … (NCT07468448) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)
1,172 participantsStarted 2026-05-30
Plain-language summary
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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Modified Rankin Scale Score \< 4 at randomization
✓. Ability to obtain informed consent prior to randomization.
Exclusion criteria
✕. 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
✕. Intended intracranial stenting for the qualifying stroke
✕. Symptomatic hemorrhagic transformation of the index stroke, or neuroradiological class 2 (PH2 type) or symptomatic class 3 on Heidelberg scale prior to randomization
What they're measuring
1
Time to first symptomatic stroke for participants
Timeframe: From randomization until end of study visit (12 months after Last Patient First Visit)