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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)
- ClinicalTrials.gov ID
- NCT07468448
- Acronym / sponsor ID
- CATIS-ICAS / CATIS-ICAS
- Conditions
- Ischemic Stroke, Intracranial Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,172 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Dual pathway inhibition | Experimental | Drug: Rivaroxabanrivaroxaban 2.5mg BID, plus clinical ASA |
| Antiplatelet therapy | Active comparator | Drug: ASAPlacebo BID, plus clinical ASA |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanLow-dose rivaroxaban (2.5 mg BID) plus clinical ASA | Drug | Dual pathway inhibition |
| ASAclopidogrel 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. | Drug | Antiplatelet therapy |
Primary outcome
Time to first symptomatic stroke for participants
Time frame: From randomization until end of study visit (12 months after Last Patient First Visit)
Time to first symptomatic stroke (including ischemic, hemorrhagic and undefined) for all participants affected, by treatment arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Taylor, BSc contact
Kanjana Perera, MD principal investigator
Population Health Research Institute, Hamilton Health Sciences, McMaster University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban and ASA in people with Ischemic Stroke and Intracranial Atherosclerosis, run by Population Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin W Reeh, MSc (905-521-2100, CATIS-ICAS@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.