Ischemic StrokePhase 3CATIS-ICASNCT07468448
Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)
A Phase 3 study testing Rivaroxaban and ASA in people with Ischemic Stroke and Intracranial Atherosclerosis, run by Population Health Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Intracranial Atherosclerosis
- What is being tested?
- Rivaroxaban and ASA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,172 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 40 years
- Ischemic stroke or high-risk TIA (motor and/ or speech involvement)
- Randomization within 30 days of index stroke
- Stroke potentially attributable to ICAS 30-99% (or flow gap on time-offlight MRA) of a major intracranial artery (internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, intracranial vertebral artery, or basilar artery) by MRA or CTA or catheter angiography.
- Modified Rankin Scale Score < 4 at randomization
- Ability to obtain informed consent prior to randomization.
Who cannot join
- Cardioembolic stroke
- Indication for long-term dual antiplatelet or anticoagulant therapy (e.g. venous thromboembolism, coronary stent, mechanical prosthetic valve)
- Intracranial arterial stenosis secondary to causes other than atherosclerosis e.g. dissection, moya moya disease
- Substantial extracranial carotid artery disease ipsilateral to the qualifying stroke with plans for carotid revascularization
- Intended intracranial stenting for the qualifying stroke
- Symptomatic hemorrhagic transformation of the index stroke, or neuroradiological class 2 (PH2 type) or symptomatic class 3 on Heidelberg scale prior to randomization
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- Previous non-traumatic intracerebral hemorrhage, non-aneurysmal subarachnoid hemorrhage (treated aneurysmal subarachnoid hemorrhage will be allowed)
- Subdural hematoma within 12 months prior to randomization or traumatic brain hemorrhage within 1 month prior to randomization
- Advanced kidney disease at randomization (eGFR <15 ml per minute)
- Platelet count less than 100,000/mm3 at enrolment or other bleeding diatheses
- Uncontrolled hypertension with BP consistently above 180 mmHg for systolic and 110mmHg for diastolic while on treatment
- Known hypersensitivity or contraindication to ASA, clopidogrel or rivaroxaban
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) or P- glycoprotein (P-gp)
- Females of childbearing potential who are not surgically sterile, pregnant, or breast-feeding
- Previous randomization to this study
- Participating in a study with an investigational drug or medical device that would interfere with the study at the time of randomization (participants that are no longer in an active arm of a study but are being followed may be randomized)
- Terminal medical illness with life expectancy less than 1 year
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amanda Taylor, BSc contact
About this study
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.
Read the 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
- Being tested
- Rivaroxaban, ASA
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Low-dose rivaroxaban (2.5 mg BID) plus clinical ASA
ASADrug
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 group | Role | What they receive |
|---|---|---|
| Dual pathway inhibition | Experimental | rivaroxaban 2.5mg BID, plus clinical ASA Receives: Drug: Rivaroxaban |
| Antiplatelet therapy | Active comparator | Placebo BID, plus clinical ASA Receives: Drug: ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first symptomatic stroke for participants
Time to first symptomatic stroke (including ischemic, hemorrhagic and undefined) for all participants affected, by treatment arm
Measured: From randomization until end of study visit (12 months after Last Patient First Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, placebo-controlled trial (RCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanjana Perera, MD, Principal investigator, Population Health Research Institute, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468448
- Sponsor's protocol ID
- CATIS-ICAS
- Acronym
- CATIS-ICAS
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided