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MEDTECH The effect of clopidogrel plus aspirin as compared with aspirin alone administered within 72 hours after the onset of acute cerebral ischemia from atherosclerosis has not been well studied.
A recent clinical trial conducted in 222 hospitals across China has investigated the effects of dual antiplatelet treatment with clopidogrel and aspirin in patients with mild ischemic stroke or high-risk transient ischemic attack (TIA) of presumed atherosclerotic cause. The study focused on the administration of this treatment within 72 hours after the onset of acute cerebral ischemia.
Study Design
- Double-blind, randomized, placebo-controlled, two-by-two factorial trial.
- Involved patients with mild ischemic stroke or high-risk TIA of presumed atherosclerotic cause who had not undergone thrombolysis or thrombectomy.
- Patients were randomly assigned to receive clopidogrel (300 mg on day 1 and 75 mg daily on days 2 to 90) plus aspirin (100 to 300 mg on day 1 and 100 mg daily on days 2 to 21) or matching clopidogrel placebo plus aspirin.
- Primary efficacy outcome was new stroke, and the primary safety outcome was moderate-to-severe bleeding — both assessed within 90 days.
Key Findings
- A total of 6,100 patients were enrolled, with 3,050 assigned to each trial group.
- A new stroke occurred in 7.3% of patients in the clopidogrel–aspirin group and in 9.2% in the aspirin group (hazard ratio, 0.79; 95% confidence interval [CI], 0.66 to 0.94; P=0.008).
- Moderate-to-severe bleeding occurred in 0.9% of patients in the clopidogrel–aspirin group and in 0.4% in the aspirin group (hazard ratio, 2.08; 95% CI, 1.07 to 4.04; P=0.03).
HCN Medical Memo
This trial studied patients with mild ischemic stroke or high-risk TIA, presumed to be from intracranial or extracranial atherosclerosis. The findings suggest that a treatment regimen of clopidogrel and aspirin, started within 72 hours of symptom onset, reduces the risk of new strokes over a 90-day period compared to aspirin alone. However, this combined therapy also increases the risk of moderate-to-severe bleeding.
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