ongoing

Intracranial Atherosclerotic Disease (ICAD) is an important and common cause of ischemic stroke, with high recurrence risk compared with other stroke subtypes. ICAD accounts for about 30-40% of strokes globally. Despite current guideline-recommended treatment, the risk of recurrent ischemic stroke in ICAD remains high demonstrating that more effective therapies are needed.

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.

Study Type

Phase III

Study Design

Double-blind, randomized, placebo-controlled trial with adaptive sample size

NO. of Countries

5-10

NO. of Sites

40-80

NO. of Participants

586-1995

Study Period

2026-2028+

Sponsor

PHRI

Canadian Institutes of Health Research

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