October 27, 2025Frontiers in Neurology1 citationsOpen Access

Effect of age on the efficacy and safety of clopidogrel plus aspirin vs aspirin alone in acute mild-to-moderate stroke: a secondary analysis of the ATAMIS trial

Structured PICO

Does clopidogrel plus aspirin improve excellent functional outcomes at 90 days in patients with acute mild-to-moderate ischemic stroke compared to aspirin alone, and is this effect modified by age?

Population

2,831 adults (aged 18 years and older) with acute mild-to-moderate ischemic stroke (baseline NIHSS score of 4-10) presenting within 48 hours of symptom onset, excluding those eligible for intravenous thrombolysis or endovascular treatment.

Intervention

Clopidogrel plus aspirin (loading dose of clopidogrel 300 mg and aspirin 100 mg on day 1; clopidogrel 75 mg and aspirin 100 mg daily on days 2-14; clopidogrel 75 mg or aspirin 100 mg daily on days 15-90).

Comparator

Aspirin alone (100-300 mg daily on days 1-14, followed by 100 mg daily on days 15-90).

Outcome

Excellent functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0-1.hard clinical

Short-term dual antiplatelet therapy with clopidogrel and aspirin improves 90-day functional outcomes compared to aspirin alone in patients aged ≥65 years with acute mild-to-moderate ischemic stroke, without significantly increasing bleeding risk.

Abstract

Objectives The association between age and the effect of antiplatelet therapy on clinical outcomes in patients with ischemic stroke remains unclear. This study aimed to explore the effect of age on the efficacy and safety of dual versus mono antiplatelet therapy in patients with mild-to-moderate ischemic stroke, based on the Antiplatelet Therapy in Acute Mild to Moderate Ischemic Stroke (ATAMIS) trial. Methods This secondary analysis was based on the full analysis set from the ATAMIS trial. The primary outcome was an excellent functional outcome at 90 days, which was defined as a modified Rankin Scale (mRS) score of 0–1. The treatment effect of clopidogrel plus aspirin versus aspirin alone on outcomes was analyzed using age as either a categorical variable (age 65 vs. ≥65) or a continuous variable. Results A total of 2,831 patients were included, with 1,249 in the subgroup aged 65 years and 1,582 in the subgroup aged ≥65 years. Compared to aspirin alone, clopidogrel plus aspirin significantly increased the likelihood of achieving an mRS score of 0–1 at 90 days in the ≥65-year age subgroup (adjusted OR, 0.77; 95% CI, 0.61–0.98; p = 0.031) but not in the 65-year age subgroup (78.02% vs. 78.62%, adjusted OR, 0.99, 95% CI, 0.75–1.32, p = 0.964). When age was analyzed as a continuous variable, the probability of an excellent functional outcome gradually decreased with advancing age in both treatment groups, but the decline was more pronounced in the aspirin-alone group, suggesting a relatively greater advantage of dual therapy among older patients. Conclusion Our findings indicate that short-term dual antiplatelet therapy is associated with improved functional outcomes in patients aged ≥65 years but not in those aged 65 years. These findings suggest that age should be considered when developing antiplatelet strategies for treating acute mild-to-moderate ischemic stroke. Clinical trial registration ClinicalTrials.gov , NCT02869009.

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