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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Genetic, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Age ≥ 40 years old, male and female.

• TIA or ischemic stroke secondary to symptomatic atherosclerotic stenosis of 30- 99% involving the intracranial ICA or MCA or posterior circulation arteries as evidenced by CT or MR angiography.

• Index TIA or ischemic stroke event occurred within past 30 days.

• Clinical indication for DAPT for at least 3 months.

Locations
Other Locations
Canada
University of Calgary
NOT_YET_RECRUITING
Calgary
Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Mark I Boulos, MD
mark.boulos@sunnybrook.ca
416-480-4473
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2027-08
Participants
Target number of participants: 100
Treatments
Experimental: Point-of-Care CYP2C19 Testing
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).
No_intervention: Standard of Care
Patients will receive standard-of-care ASA + clopidogrel.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov