Actively Recruiting
Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy in Symptomatic Intracranial Atherosclerotic Disease: A Pilot Prospective, Randomized, Open-label, Blinded-endpoint Multi-Centre Study
Led by Sunnybrook Health Sciences Centre · Updated on 2025-11-20
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of genetic testing to guide medication choice in adults who have had a stroke caused by intracranial atherosclerotic disease (ICAD). This condition involves plaque buildup in brain arteries, reducing blood flow and increasing stroke risk. The study focuses on patients aged 40 and older who recently experienced a stroke or transient ischemic attack (TIA) due to ICAD. The goal is to see if genetic testing can help select the best blood-thinning medication and if this approach is feasible and safe for patients. Participants will be randomly assigned to one of two groups. One group will receive standard care, taking clopidogrel plus aspirin daily for 90 days. The other group will undergo a genetic test using the Genomadix Cube to determine if they can process clopidogrel effectively. Based on the test, they will either take clopidogrel plus aspirin or switch to ticagrelor plus aspirin for 90 days. Brain scans and clinical assessments will be conducted at the start and after 90 days to monitor for new strokes and evaluate function and memory. During the study, participants will have brain imaging, cognitive tests, and questionnaires to assess their neurological function and quality of life. Researchers will track recruitment rates, study completion, and any adverse events, including bleeding or stroke. Secondary measures include changes in stroke volume, cognitive scores, and daily living activities. The study will last about 90 days per participant, helping inform future larger trials on personalized stroke treatment through genetic testing.
CONDITIONS
Brief Title
Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy in Symptomatic ICAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older, male and female
- Transient ischemic attack (TIA) or ischemic stroke due to symptomatic atherosclerotic narrowing (30-99%) of intracranial arteries (ICA, MCA or posterior circulation) confirmed by CT or MR angiography
- Stroke or TIA event occurred within the past 30 days
- Clinical indication to take dual antiplatelet therapy (DAPT) for at least 3 months
You will not qualify if you...
- Any contraindication to dual antiplatelet therapy (DAPT)
- Contraindication to clopidogrel or ticagrelor, such as pregnancy (pregnancy test required for women of child-bearing age)
- Need for long-term anticoagulation due to conditions like atrial fibrillation or heart valve problems
- Complete blockage (100% stenosis) of intracranial arteries causing brain ischemia
- Intracranial artery narrowing caused by conditions other than atherosclerosis
- Planned carotid artery surgery due to extracranial carotid disease
- Presence of intraluminal thrombus
- Unstable subdural hematoma within 12 months not treatable by embolization
- Previous spontaneous hemorrhagic stroke
- Traumatic brain hemorrhage within 1 month
- Living in a nursing home or needing daily nursing care or assistance with daily activities
- Intracranial tumors (except meningioma) or vascular malformations
- Life expectancy less than 6 months
- Enrollment in another conflicting clinical study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive genotype-guided or standard dual antiplatelet therapy to manage symptomatic intracranial atherosclerotic disease.
Several visits including baseline and follow-up assessments during treatment
Duration - Up to 3 months after treatment initiation
Participants are monitored for safety, stroke outcomes, cognitive function, and quality of life after treatment.
Visits at Day 5 ± 2, Day 14, and Day 90 ± 14
Trial Site Locations
Total: 2 locations
1
University of Calgary
Calgary, Alberta, Canada
Not Yet Recruiting
2
Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
Research Team
M
Mark I Boulos, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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