CATIS-ICAD Pilot
(2015)Objective
To assess the feasibility, safety, and efficacy trends of low-dose rivaroxaban plus aspirin compared with standard-of-care antiplatelet therapy in patients with recent ischemic stroke or TIA due to intracranial atherosclerotic disease (ICAD).
Study Summary
• This is a Pilot trial with only 110 patients randomized. • It showed lower incidence of stroke in the comibination therapy arm with no increased risk of bleeding.
Intervention
Low-dose rivaroxaban (2.5mg bid) plus aspirin vs. aspirin alone, initiated within 7 to 100 days of the index event.
Inclusion Criteria
Patients aged ≥40 years with acute ischemic stroke or high-risk transient ischemic attack due to ICAD.
Study Design
Arms: Aspirin vs. Aspirin + Rivaroxaban
Patients per Arm: Total of 110 patients were randomized between both arms
Outcome
• Primary safety outcome: Hemorrhagic stroke (no events in either arm); • Main efficacy end point: Composite of ischemic stroke or covert brain infarct on MRI; • Composite efficacy outcome: 15.7% (combination arm) vs. 24.0% (aspirin arm); HR 0.78 ([95% CI, 0.32–1.93]; P=0.59) (Not statistically significant)