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

NCT ID: NCT06714526

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-07
• Study Completion Date: 2027-08-31

Brief 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.

Conditions

Intracranial Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Point-of-Care CYP2C19 Testing

Intervention Type: GENETIC

Genetic testing with the Genomadix cube to determine P2Y12 inhibitor

ticagrelor + aspirin

Intervention Type: 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

Intervention Type: DRUG

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

Standard of Care

Patients will receive standard-of-care ASA + clopidogrel.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Point-of-Care CYP2C19 Testing

Genetic testing with the Genomadix cube to determine P2Y12 inhibitor

Intervention Type: GENETIC

ticagrelor + aspirin

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

Intervention Type: DRUG

clopidogrel + aspirin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Any contraindication to DAPT.
• Any contraindication to use of clopidogrel (Plavix) or ticagrelor (Brilinta), such as pregnancy. A pregnancy test will be performed on all women of child-bearing age prior to enrollment in the study.
• Indication for chronic anticoagulation based on guideline recommendations or investigator's judgment (e.g., atrial fibrillation, mechanical heart valve, intracardiac clot, dilated cardiomyopathy, ejection fraction <30%, etc.).
• Intracranial arterial occlusion (i.e. 100% stenosis) responsible for the acute brain ischemia.
• Intracranial arterial stenosis secondary to causes other than atherosclerosis.
• Extracranial carotid disease with a plan for carotid revascularization.
• Intraluminal thrombus.
• Unstable subdural hematoma within 12 months of randomization not amenable to embolization.
• Previous spontaneous hemorrhagic stroke.
• Traumatic brain hemorrhage within 1 month of randomization.
• Living in a nursing home or requiring daily nursing care or assistance with activities of daily living.
• Intracranial tumor (except meningioma) or any intracranial vascular malformation.
• Life expectancy less than 6 months.
• Enrolment in another study that would conflict with the current study.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark I Boulos, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: NOT_YET_RECRUITING

Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mark I Boulos, MD

Role: CONTACT

mark.boulos@sunnybrook.ca

416-480-4473

Facility Contacts

Mohammed Almekhlafi

Role: primary

mohammed.almekhlafi1@ucalgary.ca

413-944-1883

Mark I Boulos, MD, MSc

Role: primary

mark.boulos@utoronto.ca

4164804473

Other Identifiers

5902

Identifier Type: -

Identifier Source: org_study_id