Trial Summary
What is the purpose of this trial?
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.
Research Team
Mark I Boulos, MD, MSc
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
This trial is for adults who've had a stroke due to plaque build-up in brain arteries (ICAD). Participants must be willing to undergo genetic testing or take standard medication, Clopidogrel, for 90 days. Specific eligibility criteria are not provided but typically include factors like age, medical history, and the ability to comply with study requirements.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Clopidogrel (Antiplatelet Agent)
- Ticagrelor (Antiplatelet Agent)
Clopidogrel is already approved in European Union, United States, Canada, Japan, China for the following indications:
- Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
- Acute coronary syndrome
- Reduction of myocardial infarction and stroke in patients with acute coronary syndrome
- Reduction of myocardial infarction and stroke in patients with recent myocardial infarction, recent stroke, or established peripheral arterial disease
- Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
- Acute coronary syndrome
- Prevention of recurrence of ischemic cerebrovascular disorder
- Prevention of recurrence of myocardial infarction
- Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
- Acute coronary syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor