CATIS-ICAD is the first pilot RCT assessing safety of low-dose rivaroxaban plus ASA in patients with recent ischemic stroke/high-risk TIA secondary to intracranial atherosclerotic disease (ICAD), an area where a huge interest exists within the stroke community.

Primary endpoints:

Demonstrating comparable safety to antiplatelet therapy is likely to have far reaching clinical impact, as this combination therapy then potentially could be used for patients with both intracranial and extracranial atherosclerotic disease. (The COMPASS trial already established that it is safe and effective in stroke prevention in extracranial atherosclerotic disease.)

Demonstration of safety and a trend towards efficacy in rivaroxaban plus ASA arm when compared with the ASA arm will provide a platform for a phase III efficacy trial.

CATIS-ICAD Protocol - Download PDF
Study Type

Interventional - Drug

Study Design

Randomized, open-label, blinded endpoint, pilot trial

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NO. of Sites


NO. of Participants


Study Period




HHS (HIF grant)

Bayer (IP)

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