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

Sponsor
Population Health Research Institute
Study ID
NCT07468448
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rivaroxaban — DRUG
    Low-dose rivaroxaban (2.5 mg BID) plus clinical ASA
  • ASA — DRUG
    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.

Study Details

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.

Key Dates

First listed
Mar 12, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
1,172 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dual pathway inhibition
    rivaroxaban 2.5mg BID, plus clinical ASA
  • Active Comparator: Antiplatelet therapy
    Placebo BID, plus clinical ASA

Primary Outcome Measure

Time to first symptomatic stroke for participants [ Time Frame: From randomization until end of study visit (12 months after Last Patient First Visit) ]

Central Contacts

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