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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
101
Pts will receive rivaroxaban + aspirin
Pts will receive ASA
Alberta Health Services
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Recruitment rate
Recruitment rate of potentially eligible patients from neurology clinics
Time frame: 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
Time frame: From randomization to end of recruitment (2 years)
Retention rate
Rate of patients who remain in the clinical trial until EOS or qualifying event
Time frame: 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
Time frame: From randomization to End of Study (median 2 years)
Major hemorrhage
Major hemorrhage as defined by ISTH criteria
Time frame: 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
Time frame: 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
Time frame: From randomization to End of Study (median 2 years)
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Hamilton, Ontario, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Rhema Research Institute
Owen Sound, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Recurrent ischemic stroke
Recurrent ischemic stroke that is restricted to the area of the qualifying stenosis
Time frame: From randomization to End of Study (median 2 years)
Composite of stroke, myocardial infarction or vascular death
Composite of stroke, MI or vascular death
Time frame: From randomization to End of Study (median 2 years)