RecruitingNAINTERVENTIONAL

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

This study aims to find out if using a genetic test can help doctors choose the best medication to prevent future strokes in people who have had a stroke due to narrowed arteries in their brain. Some people have a gene variation that makes a common stroke medicine, clopidogrel, less effective for them. Another medicine, ticagrelor, might work better for these individuals. The study will test if giving a genetic test to patients can help decide between these two medicines, alongside aspirin. Researchers will check for any new strokes using brain scans and monitor memory and daily function over 90 days. This initial study will help determine if this approach is safe and practical for future, larger studies.

At a glance

Status

Recruiting

Phase

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

100

Start

07 Oct 2025

Estimated completion

01 Aug 2027

Intracranial Atherosclerosis

What is this study about?

When arteries inside your brain become narrow due to a build-up of fatty deposits, it's called intracranial atherosclerosis, or ICAD. This narrowing can reduce blood flow to your brain and lead to a stroke. To help prevent future strokes, doctors often prescribe a medicine called clopidogrel, which works by stopping blood clots from forming.

However, for some people, clopidogrel doesn't work as well as it should. This is because they have a slight difference in their genes that affects how their body processes the medicine. For these individuals, another medication called ticagrelor might be a better option. This study wants to see if we can use a quick genetic test to find out which medicine would be most effective for each patient.

Patients taking part will either receive standard care, which means they'll take clopidogrel and aspirin, or they'll get a genetic test first. If they have the gene variation making clopidogrel less effective, they'll be given ticagrelor and aspirin instead. Everyone will be monitored closely with brain scans and will answer questions about their memory and daily activities. This research is a first step to understand if using genetic information can safely and effectively help doctors choose the best stroke prevention medicine, hopefully leading to better health outcomes in the future.

Key takeaways

This study aims to discover if genetic testing can guide stroke medication choice.
It focuses on people who have had a stroke due to narrowed brain arteries.
Participants will take either clopidogrel or ticagrelor, plus aspirin.
Brain scans and questionnaires will track progress over 3 months.
It's a first step to see if this approach is safe and practical for future stroke prevention.

Who may be eligible?

To be able to join this study, you would need to be at least 40 years old, male or female. You must have had a 'mini-stroke' (TIA) or a stroke caused by narrowed arteries inside your brain recently, within the last month. Also, your doctor must think you need to take two anti-clotting medicines (like clopidogrel and aspirin) for at least three months.

There are several reasons why you might not be able to join. For example, if you have any medical condition that prevents you from taking clopidogrel or ticagrelor (like being pregnant), or if you already need regular blood-thinning medication for other conditions, such as certain heart problems. If you have another type of brain tumour (apart from a meningioma) or a dangerous bleeding problem in your brain, you would also not be able to take part.

Finally, if you need full-time nursing care, are expected to live for less than six months, or are already involved in another medical study that might clash with this one, you would not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Have you had a stroke or mini-stroke (TIA) in the last month due to narrowed brain arteries?
Do you need to take two anti-clotting medicines for at least 3 months?
Are you not pregnant and don't have any bleeding disorders or specific heart conditions that would prevent you from taking these medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will take clopidogrel and aspirin, which is the usual treatment. The other group will have a genetic test. Based on the results of that test, you'll either take clopidogrel and aspirin, or ticagrelor and aspirin. All participants will take their assigned medication for 90 days.

During these 90 days, you'll have a brain scan at the beginning of the study and again at the end, around day 90. You will also complete some questionnaires and tests. These will help us understand your memory, how you're feeling, and how you manage your daily activities, both at the start and the end of the 90-day period. The total duration of active participation in the study, including medication and follow-up, will be about 3 months.

Potential risks and benefits

Participating in this study might offer a potential benefit if the genetic testing helps identify a more effective medication for you, which could reduce your risk of another stroke. However, as with any medical treatment, there are potential risks associated with taking medications like clopidogrel or ticagrelor, mainly an increased risk of bleeding. There are also risks involved with having brain scans, although these are generally very low. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University of Calgary
Verified postcode
Calgary, Canada· Not yet recruiting
Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Intracranial Atherosclerosis?

It's when the blood vessels inside your brain become narrowed due to fatty deposits, which can lead to a stroke.

What is a 'genetic test' in this study?

It's a test to see if your body processes a common stroke medicine (clopidogrel) effectively, based on your genes.

What are clopidogrel and ticagrelor?

They are medicines that help stop blood clots from forming, which can prevent strokes.

How long will I take the study medication?

You will take the assigned medication along with aspirin for 90 days (about 3 months).

Will I know if I have the gene variation?

This study is designed to guide treatment based on the test, but specific details about how test results are shared will be explained by the study team.

How to find out more

Mark I Boulos, MD

mark.boulos@sunnybrook.ca 416-480-4473 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.