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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (riva + ASA) | Experimental | Rivaroxaban 2.5mg bid + aspirin 81mg qd |
|
| Control (ASA alone) | Active Comparator | Aspirin 81 mg qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 2.5 Mg Oral Tablet bid | Drug | Pts will receive rivaroxaban + aspirin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate of potentially eligible patients from neurology clinics | 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 | From randomization to end of recruitment (2 years) |
| Retention rate | Rate of patients who remain in the clinical trial until EOS or qualifying event | 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 | From randomization to End of Study (median 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Major hemorrhage | Major hemorrhage as defined by ISTH criteria | From randomization to End of Study (median 2 years) |
| Combination of ISTH major hemorrhages & clinically-relevant non-major hemorrhages |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kanjana S. Perera, MD, FRCPC | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services | Calgary | Alberta | T2N 2T9 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39781748 | Derived | 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. |
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investigator-initiated, open-label, blinded endpoint assessment, controlled, randomized pilot trial (PROBE design)
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Blinded assessment of endpoint
| Acetylsalicyclic acid 81 mg tablet qd | Drug | Pts will receive ASA |
|
|
Major hemorrhage and clinically relevant non-major as per ISTH criteria
| 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 | 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 | From randomization to End of Study (median 2 years) |
| Composite of stroke, myocardial infarction or vascular death | Composite of stroke, MI or vascular death | From randomization to End of Study (median 2 years) |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| Rhema Research Institute | Owen Sound | Ontario | N4K 6M9 | Canada |
| Sunnybrook Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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