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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Nov 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how genetic testing can help doctors choose the best medication for patients who have had a stroke caused by plaque build-up in the brain, known as intracranial atherosclerosis (ICAD). The trial will compare the usual treatment, which involves taking the medication Clopidogrel for 90 days, to a personalized approach where patients first undergo a genetic test. Depending on the results, they may take either Clopidogrel or a different medication called Ticagrelor for the same period. This research aims to see if using genetic information can improve treatment and reduce the risk of future strokes.

To be eligible for this trial, participants must be at least 40 years old and have recently experienced a stroke or a transient ischemic attack (TIA), which is sometimes called a "mini-stroke." They should also need dual antiplatelet therapy (DAPT) for at least three months. If you decide to participate, you will have a brain scan and complete some tests about your memory and daily function at the start and again after 90 days. This trial is important because it could lead to better treatment strategies for stroke patients based on their genetic make-up, potentially improving their overall health outcomes.

Gender

ALL

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.