Dual Antiplatelet Therapy and Immediate Intensive Statin in Mild Ischemic Stroke: A Randomized Trial

Area of Science:

• Neurology
• Cardiology
• Clinical Trials

Background:

• Previous research indicated benefits of clopidogrel-aspirin and intensive statin therapy for acute ischemic stroke.
• The synergistic effect of combining these treatments remained unclear.

Purpose of the Study:

• To investigate the efficacy and safety of combining clopidogrel-aspirin with immediate intensive statin therapy in patients experiencing acute mild ischemic stroke or transient ischemic attack (TIA).

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled trial with a 2x2 factorial design was conducted across 222 hospitals in China.
• Eligible patients with acute mild ischemic stroke or TIA of presumed atherosclerotic cause within 72 hours of symptom onset were enrolled.
• Participants received either clopidogrel-aspirin or aspirin alone, combined with either immediate or delayed intensive statin therapy.

Main Results:

• New stroke within 90 days occurred in 7.6% of patients receiving clopidogrel-aspirin plus immediate intensive statin, 7.0% with clopidogrel-aspirin plus delayed statin, and 8.5% with aspirin plus immediate statin, compared to 9.9% in the aspirin plus delayed statin group.
• Moderate-to-severe bleeding was observed in 1.1% of the clopidogrel-aspirin plus immediate statin group, 0.7% in the clopidogrel-aspirin plus delayed statin group, 0.4% in the aspirin plus immediate statin group, and 0.5% in the aspirin plus delayed statin group.
• The combination of clopidogrel-aspirin and delayed intensive statin demonstrated a statistically significant reduction in new stroke risk compared to aspirin plus delayed statin (HR 0.69, 95% CI 0.54-0.89).

Conclusions:

• The combination of clopidogrel-aspirin and delayed intensive statin therapy is superior to aspirin plus delayed intensive statin in reducing the risk of new stroke in patients with mild ischemic stroke or TIA of atherosclerotic origin.
• The observed benefit in reducing new stroke risk was primarily attributed to clopidogrel-aspirin, with no significant difference compared to clopidogrel-aspirin plus immediate statin.
• While effective, the combination treatment was associated with a low but increased risk of moderate-to-severe bleeding.