Genetic Testing for Stroke Treatment (NUANCE-ICAD Trial)

Palo Alto (17 mi)

Overseen byMark I Boulos, MD, MSc

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

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.

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

I need dual antiplatelet therapy for at least 3 months.

I am 40 years old or older.

I had a stroke or mini-stroke due to narrowed arteries in my brain.

I had a stroke or mini-stroke in the last 30 days.

Exclusion Criteria

I cannot take dual antiplatelet therapy.

I cannot take clopidogrel or ticagrelor due to reasons like pregnancy.

I have a blood clot inside a blood vessel.

I have a complete blockage in an artery in my brain causing a stroke.

I have had a bleeding in my brain that cannot be treated with a procedure, within the last year.

I live in a nursing home or need daily help with personal care.

I have a brain tumor (not meningioma) or a brain blood vessel abnormality.

My brain artery narrowing is not due to hardening of the arteries.

I have a blockage in the neck artery on the same side as my brain ischemia and am planning surgery to fix it.

Treatment Details

The trial tests if using genetic testing to choose between two blood-thinning medications—Ticagrelor or Clopidogrel—can prevent further strokes in ICAD patients. One group gets standard care with Clopidogrel; the other gets Ticagrelor based on their gene test results.

2Treatment groups

Experimental Treatment

Active Control

Group I: Point-of-Care CYP2C19 TestingExperimental Treatment3 Interventions

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 II: Standard of CareActive Control1 Intervention

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

Clopidogrel is already approved in European Union, United States, Canada, Japan, China for the following indications:

🇪🇺 Approved in European Union as Plavix for:

Prevention of atherothrombotic events in patients with myocardial infarction, stroke, or peripheral arterial disease
Acute coronary syndrome

🇺🇸 Approved in United States as Plavix for:

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

🇨🇦 Approved in Canada as Plavix for: