NCT07468448

Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,172 (estimated)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

CATIS-ICAD will recruit approximately 1172 consenting participants presenting with ischemic stroke secondary to ICAD within 30 days from symptom onset at approximately 80 high-volume stroke research centers across Canada, Europe, South America and Asia over 48 months. Participants will be randomly assigned (1:1) to oral intake of rivaroxaban 2.5 mg twice daily plus aspirin or clopidogrel 75 mg daily plus aspirin followed by aspirin plus placebo. They will be followed to a common termination date, defined as approximately 12 months following the end of recruitment (estimated mean follow-up of 36 months).

Conditions

• Ischemic Stroke
• Intracranial Atherosclerosis

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Low-dose rivaroxaban (2.5 mg BID) plus clinical ASA
DRUG	ASA	clopidogrel 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.

Timeline

• Start date: 2026-05-30
• Primary completion: 2029-12-30
• Completion: 2029-12-30
• First posted: 2026-03-12
• Last updated: 2026-03-12