RecruitingNot ApplicableNCT06714526

Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy in Symptomatic ICAD

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 (PROBE) Multi- Centre Study


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

100 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Point-of-Care CYP2C19 Testing, a drug called clopidogrel + aspirin, and others for people with intracranial atherosclerosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 40 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICPoint-of-Care CYP2C19 Testing

Genetic testing with the Genomadix cube to determine P2Y12 inhibitor

DRUGticagrelor + aspirin

If patients are poor or intermediate metabolizers of clopidogrel, they will receive ticagrelor (90 mg PO BID) + aspirin (81 mg PO daily)

DRUGclopidogrel + aspirin

Normal, rapid, and ultra-rapid metabolizers of clopidogrel will receive 75 mg PO daily of clopidogrel and 81 mg PO daily of aspirin.


Locations(2)

University of Calgary

Calgary, Alberta, Canada

Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06714526


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