Ischemic StrokePhase 3NCT04142125
Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease
A Phase 3 study testing Rivaroxaban 2.5 Mg Oral Tablet bid and Acetylsalicyclic acid 81 mg tablet qd in people with Ischemic Stroke and Intracranial Atherosclerotic Disease, run by Population Health Research Institute at 10 sites in Canada.
Trial summary
CATIS-ICAD is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Intracranial Atherosclerotic Disease
- What is being tested?
- Rivaroxaban 2.5 Mg Oral Tablet bid and Acetylsalicyclic acid 81 mg tablet qd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 10 sitesCanada
- Study dates
- 3 Feb 2020to 18 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Recent brain ischemia attributed to intracranial atherosclerotic stenosis of 30-99% as evidenced by CT or MR angiography, occurring between 7 to 100 days prior to randomization and consisting of either:
- a high-risk TIA defined as TIA with motor and/or speech involvement or
- an ischemic stroke
- Written informed consent consistent with local regulations governing research in human subjects
Who cannot join
- Indication for DAPT for > 90 days on guideline recommendations or investigator ́s judgment; e.g., cardiac stenting.
- Indication for chronic anticoagulation based on guideline recommendations or investigator ́s judgment; e.g. patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state
- Atrial fibrillation or a history of atrial fibrillation
- Intracranial arterial occlusion (e.g. 100% stenosis) responsible for the acute brain ischemia
- Intracranial arterial stenosis secondary to causes other than atherosclerosis
- Extracranial carotid artery disease ipsilateral to the qualifying brain ischemia with a plan for carotid revascularization
Show all 23Show fewer
- Intraluminal thrombus
- Subdural hematoma within 12 months of randomization
- Previous spontaneous hemorrhagic stroke (e.g. intracerebral or subarachnoid hemorrhage)
- Traumatic brain hemorrhage within 1 month of randomization
- Contraindication for MRI scan (e.g. pacemaker incompatible with MRI)
- Advanced kidney disease (recent estimated GFR <30 ml per minute)
- Modified Rankin Scale (mRS) >=4 at entry
- Platelet count less than 100,000/mm3 at enrolment or other bleeding diathesis
- Uncontrollable hypertension with systolic BP/ diastolic BP consistently above180/100mmHg after treatment
- Known hypersensitivity to either ASA or rivaroxaban
- Life expectancy less than 6 months
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e., human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, or posaconazole, if used systemically
- Female of childbearing potential who are not surgically sterile, or, if sexually active not willing to use adequate contraceptive measures with a failure rate less than 1% per year (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study, as well as pregnant or breast-feeding women
- Inability to adhere to study procedures
- Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
- Previous randomization to this study or participating in a study with an investigational drug or medical device at the time of randomization
- Antiphospholipid antibody syndrome
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Alberta Health Services
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5A5
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
Rhema Research Institute
Owen Sound, Ontario, N4K 6M9
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial
CATIS-ICAD is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone.
- Being tested
- Rivaroxaban 2.5 Mg Oral Tablet bid, Acetylsalicyclic acid 81 mg tablet qd
- Keywords
- Pilot study, Rivaroxaban, Factor Xa Inhibitors, Intracranial Atherosclerotic Disease
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 2.5 Mg Oral Tablet bidDrug
Also called Xarelto
Pts will receive rivaroxaban + aspirin
Acetylsalicyclic acid 81 mg tablet qdDrug
Also called Aspirin
Pts will receive ASA
| Study group | Role | What they receive |
|---|---|---|
| Experimental (riva + ASA) | Experimental | Rivaroxaban 2.5mg bid + aspirin 81mg qd Receives: Drug: Rivaroxaban 2.5 Mg Oral Tablet bid; Drug: Acetylsalicyclic acid 81 mg tablet qd |
| Control (ASA alone) | Active comparator | Aspirin 81 mg qd Receives: Drug: Acetylsalicyclic acid 81 mg tablet qd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate of potentially eligible patients from neurology clinics
Measured: From randomization to end of recruitment (2 years)
Refusal rate
Rate of patients who refuse to participate in the clinical trial who otherwise are eligible for the study
Measured: From randomization to end of recruitment (2 years)
Retention rate
Rate of patients who remain in the clinical trial until EOS or qualifying event
Measured: From randomization to End of Study (median 2 years)
Incidence rate of Intracranial hemorrhage
Rate of patients who experience an intracranial hemorrhage during the study
Measured: From randomization to End of Study (median 2 years)
Secondary outcomes (5)
Major hemorrhage
Major hemorrhage as defined by ISTH criteria
Measured: From randomization to End of Study (median 2 years)
Combination of ISTH major hemorrhages & clinically-relevant non-major hemorrhages
Major hemorrhage and clinically relevant non-major as per ISTH criteria
Measured: From randomization to End of Study (median 2 years)
Recurrent ischemic stroke & MRI-detected incident covert brain infarction
Symptomatic investigator reported ischemic stroke and MRI detected covert brain infarct as determined by MRI corelab reading baseline and end of study MRI
Measured: From randomization to End of Study (median 2 years)
Recurrent ischemic stroke
Recurrent ischemic stroke that is restricted to the area of the qualifying stenosis
Measured: From randomization to End of Study (median 2 years)
Composite of stroke, myocardial infarction or vascular death
Composite of stroke, MI or vascular death
Measured: From randomization to End of Study (median 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start3 Feb 2020
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- investigator-initiated, open-label, blinded endpoint assessment, controlled, randomized pilot trial (PROBE design)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanjana S. Perera, MD, FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142125
- Sponsor's protocol ID
- CATIS-ICAD
- Status last verified
- Sep 2023
- First submitted
- 25 Oct 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perera KS, Sharma MA, Eikelboom JW, Ng KKH, Field TS, Buck BH, Hill MD, Stotts G, Casaubon LK, Mandzia J, Katsanos AH, Yip S, Shoamanesh A, Young GB, Appireddy R, Nayar S, Swartz R, Taylor A, Carrier A, Srivastava A, Deshmukh AS, Zhao R, Hart RG; CATIS-ICAD Investigators. Combination Antithrombotic Therapy for Reduction of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease. Stroke. 2025 Feb;56(2):380-389. doi: 10.1161/STROKEAHA.124.047715. Epub 2025 Jan 9.
PubMed 39781748
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT04142125
- Acronym / sponsor ID
- CATIS-ICAD
- Keywords
- Pilot study, Rivaroxaban, Factor Xa Inhibitors, Intracranial Atherosclerotic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 29 Oct 2019 (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-ICAD is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- investigator-initiated, open-label, blinded endpoint assessment, controlled, randomized pilot trial (PROBE design)
| Arm | Type | Receives |
|---|---|---|
| Experimental (riva + ASA) | Experimental | Drug: Rivaroxaban 2.5 Mg Oral Tablet bid, Drug: Acetylsalicyclic acid 81 mg tablet qdRivaroxaban 2.5mg bid + aspirin 81mg qd |
| Control (ASA alone) | Active comparator | Drug: Acetylsalicyclic acid 81 mg tablet qdAspirin 81 mg qd |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 40 years
- Recent brain ischemia attributed to intracranial atherosclerotic stenosis of 30-99% as evidenced by CT or MR angiography, occurring between 7 to 100 days prior to randomization and consisting of either:
- Written informed consent consistent with local regulations governing research in human subjects
Key exclusion criteria (23 listed)
- Indication for DAPT for > 90 days on guideline recommendations or investigator ́s judgment; e.g., cardiac stenting.
- Indication for chronic anticoagulation based on guideline recommendations or investigator ́s judgment; e.g. patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state
- Atrial fibrillation or a history of atrial fibrillation
- Intracranial arterial occlusion (e.g. 100% stenosis) responsible for the acute brain ischemia
- Intracranial arterial stenosis secondary to causes other than atherosclerosis
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 |
|---|---|---|
| Rivaroxaban 2.5 Mg Oral Tablet bidAlso: XareltoPts will receive rivaroxaban + aspirin | Drug | Experimental (riva + ASA) |
| Acetylsalicyclic acid 81 mg tablet qdAlso: AspirinPts will receive ASA | Drug | Control (ASA alone), Experimental (riva + ASA) |
Primary outcome
Recruitment rate
Time frame: From randomization to end of recruitment (2 years)
Recruitment rate of potentially eligible patients from neurology clinics
Refusal rate
Time frame: From randomization to end of recruitment (2 years)
Rate of patients who refuse to participate in the clinical trial who otherwise are eligible for the study
Retention rate
Time frame: From randomization to End of Study (median 2 years)
Rate of patients who remain in the clinical trial until EOS or qualifying event
Incidence rate of Intracranial hemorrhage
Time frame: From randomization to End of Study (median 2 years)
Rate of patients who experience an intracranial hemorrhage during the study
5 secondary outcomes
Major hemorrhage
Time frame: From randomization to End of Study (median 2 years)
Combination of ISTH major hemorrhages & clinically-relevant non-major hemorrhages
Time frame: From randomization to End of Study (median 2 years)
Recurrent ischemic stroke & MRI-detected incident covert brain infarction
Time frame: From randomization to End of Study (median 2 years)
Recurrent ischemic stroke
Time frame: From randomization to End of Study (median 2 years)
Composite of stroke, myocardial infarction or vascular death
Time frame: From randomization to End of Study (median 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 39781748Perera KS, Sharma MA, Eikelboom JW, Ng KKH, Field TS, Buck BH, Hill MD, Stotts G, Casaubon LK, Mandzia J, Katsanos AH, Yip S, Shoamanesh A, Young GB, Appireddy R, Nayar S, Swartz R, Taylor A, Carrier A, Srivastava A, Deshmukh AS, Zhao R, Hart RG; CATIS-ICAD Investigators. Combination Antithrombotic Therapy for Reduction of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease. Stroke. 2025 Feb;56(2):380-389. doi: 10.1161/STROKEAHA.124.047715. Epub 2025 Jan 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kanjana S. Perera, MD, FRCPC principal investigator
Hamilton Health Sciences Corporation
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban 2.5 Mg Oral Tablet bid and Acetylsalicyclic acid 81 mg tablet qd in people with Ischemic Stroke and Intracranial Atherosclerotic Disease, run by Population Health Research Institute at 10 sites in Canada.
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 5 inclusion and 23 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: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: From randomization to end of recruitment (2 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04142125, which also lists 1 linked publication.
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 26 Sep 2023.