This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or high-risk transient ischemic attack who are sensitive to clopidogrel.
Participants who present within 48 hours of symptom onset and meet the eligibility criteria will receive loading doses of clopidogrel and aspirin, followed by platelet aggregation function testing. Eligible clopidogrel-sensitive participants will be randomized to receive either 7 days of dual antiplatelet therapy followed by clopidogrel monotherapy or standard 21-day dual antiplatelet therapy followed by single antiplatelet therapy. The primary efficacy outcome is new stroke within 90 days after randomization.
1.Age 18 years or older. 2.Diagnosis of acute non-disabling ischemic stroke or transient ischemic attack according to World Health Organization criteria, meeting one of the following definitions: acute non-disabling ischemic stroke, defined as a National Institutes of Health Stroke Scale score of 5 or lower at enrollment; or high-risk transient ischemic attack, defined as an ABCD2 score of 4 or higher.
None
Parallel
Clopidogrel
DrugClopidogrel will be administered according to the assigned antiplatelet strategy. Participants receive a loading dose during screening and then clopidogrel 75 mg orally once daily during the assigned treatment period.
Aspirin
DrugAspirin will be administered according to the assigned antiplatelet strategy. Participants receive aspirin during screening and then aspirin 100 mg orally once daily during the assigned treatment period.
Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
New stroke at prespecified follow-up visits
New vascular events
Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.
Modified Rankin Scale score
The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.
New ischemic stroke
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