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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,836
Clopidogrel 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 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.
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
Time frame: within 90 days
New stroke at prespecified follow-up visits
Time frame: At Day 7 or hospital discharge, Day 30 and 1 year after randomization
New vascular events
Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.
Time frame: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization
Modified Rankin Scale score
The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.
Time frame: At Day 30, Day 90, 1 year, and 2 years after randomization
New ischemic stroke
Time frame: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization
Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)
Time frame: At 24 hours and at Day 7 or hospital discharge after randomization
Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]
It is usually represented by a value between 0 and 1, where 1 represents perfect health, 0 represents death, and the intermediate values reflect different degrees of health status.
Time frame: At Day 90 after randomization
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