Genotype-guided P2Y12 inhibitor selection versus standard clopidogrel for symptomatic intracranial atherosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with a recent TIA or ischemic stroke caused by 30–99% intracranial atherosclerotic stenosis are randomized to either genotype-guided antiplatelet selection or conventional clopidogrel therapy. The genotype arm undergoes point-of-care CYP2C19 testing and patients with loss-of-function alleles are given ticagrelor plus aspirin while others receive clopidogrel plus aspirin; the standard arm receives clopidogrel plus aspirin for 90 days. The trial targets enrollment within 30 days of the index event and requires clinical indication for at least three months of dual antiplatelet therapy. The primary aim is to see if genotype-guided selection reduces recurrent ischemic events compared with routine clopidogrel-based therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dr. Mark I. Boulos - Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting
• University of Calgary
  Calgary, Alberta, Canada Not yet recruiting

Study contacts

• Principal investigator: Mark I Boulos, MD — Sunnybrook Health Sciences Centre
• Study coordinator: Mark I Boulos, MD
• Email: mark.boulos@sunnybrook.ca
• Phone: 416-480-4473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.