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Stroke is an important cause of death, disability, and memory problems in adults. The build-up of plaque in arteries inside the brain is known as "intracranial atherosclerotic disease" or "ICAD" for short, and can reduce blood flow in the brain. Clopidogrel is a medicine used to prevent strokes because it stops blood from clotting. However, there are some people who do not get as much benefit from Clopidogrel because of differences in their genes; they have a variation in a certain gene and their body is not able to properly process Clopidogrel. Another medication called Ticagrelor can benefit people who have this genetic variation. The study investigators will randomize patients who have had a stroke due to ICAD to receive genetic testing, or standard of care. The standard-of-care group will take Clopidogrel for 90 days. The genetic testing group will complete a genetic test to see if they can properly process Clopidogrel. Depending on the results of the genetic test, patients will either take Clopidogrel or Ticagrelor for 90 days. All patients will have a brain scan at baseline and 90 days to see if they had any new strokes. Patients will also complete tests and questionnaires about function and memory at baseline and 90 days. This study will be one of the first to see if it is feasible and safe to use genetic testing to help choose medications for patients who have had a stroke. This will help the study investigators design a larger study that can test if genetic testing in stroke patients reduces future stroke risk and improves health outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Point-of-Care CYP2C19 Testing | Experimental | Patients will undergo point-of-care CYP2C19 testing with the Research Use Only (RUO) Genomadix Cube to inform the choice of P2Y12 inhibitor (i.e. clopidogrel vs ticagrelor). |
|
| Standard of Care | No Intervention | Patients will receive standard-of-care ASA + clopidogrel. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-Care CYP2C19 Testing | Genetic | Genetic testing with the Genomadix cube to determine P2Y12 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recruitment | The number of patients who provide informed consent, or are deemed ineligible after screening. | Through study completion, an average of 90 days |
| Rate of study completion | The number of patients who complete the entire study protocol | Through study completion, an average of 90 days |
| Rate of protocol deviations | The number of patients who encounter at least one protocol deviation during the study | Through study completion, an average of 90 days |
| Proportion of patients with Symptomatic intracerebral hemorrhage (ICH) | New symptomatic ICH OR worsening existing ICH with a ≥33% increase in hematoma volume AND NIHSS score increase of ≥4 points AND clinical change is thought to be attributable to ICH | Through study completion, an average of 90 days |
| Proportion of patients with major extracranial bleeding | Bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobulin by 20g/L or more | Through study completion, an average of 90 days |
| Proportion of patients with non-bleeding adverse events | Non-bleeding adverse events related to the study drug including dyspnea, bradyarrhythmia, and/or chest pain | Through study completion, an average of 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who have Microembolic Signals on Transcranial Doppler Ultrasound | Day 5 ± 2 | |
| Change in volume of ischemic strokes and white matter hyperintensities (optional) | Day 0 + 14 and Day 90 ± 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark I Boulos, MD | Contact | 416-480-4473 | mark.boulos@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark I Boulos, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Not yet recruiting | Calgary | Alberta | Canada |
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| ticagrelor + aspirin | Drug | If patients are poor or intermediate metabolizers of clopidogrel, they will receive ticagrelor (90 mg PO BID) + aspirin (81 mg PO daily) |
|
| clopidogrel + aspirin | Drug | Normal, rapid, and ultra-rapid metabolizers of clopidogrel will receive 75 mg PO daily of clopidogrel and 81 mg PO daily of aspirin. |
|
| Change in number of ischemic strokes and white matter hyperintensities | Day 0 + 3 and Day 90 ± 14 |
| Number of patients with ischemic stroke, myocardial infarction, or death | Day 90 ± 14 |
| Change in Montreal Cognitive Assessment (MoCA) score from baseline to follow-up | To MoCA is a validated cognitive screening tool. Possible scores range from 0 (worst score) to 31 (best score). Change = Follow-up - baseline. | Day 0 and Day 90 ± 14 |
| Change in NIH Stroke Scale (NIHSS) score from baseline to follow-up | This scale is a 15 item tool used to quantify stroke severity. Scores range from 0 (no stroke) to 42 (most severe stroke). Change = Follow-up - baseline. | Day 0 and Day 90 ± 14 |
| Change or shift in modified Rankin Scale (mRS) score from baseline to follow-up | The MRS is a single item rating of stroke outcomes. Scores range from 0 (no symptoms) to 6 (death). Change = Follow-up - baseline. | Day 0 and Day 90 ± 14 |
| Self-reported Quality of Life as assessed by the EQ-5D-5L | The EQ-5D-5L questionnaire has 5 dimensions: Mobility, Self-Care, Usual Activity, Pain/Discomfort, Anxiety/Depression, with each dimension rated on a level from 1-5 where higher scores indicate more severe problems. | Day 90 ± 14 |
| Self-reported Dementia Screening assessed by the AD8 Dementia Screening Interview | The AD8 Dementia Screening Interview has 8 questions that ask if there has been a change in the last several years caused by cognitive (thinking and memory) problems. The score is the sum of all items marked "Yes, A change". | Day 90 ± 14 |
| Self-reported functional status assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale | The Lawton-Brody Instrumental Activities of Daily Living Scale has 8 categories where participants can rate their functional level. Scores range from 0 (low function, dependent) to 8 (high function, independent). | Day 90 ± 14 |
| Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N3M5 | Canada |
|
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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