ATAMIS
Trial question
What is the role of dual antiplatelet therapy in patients with mild-to-moderate AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 2915
2915 patients (1020 female, 1895 male)
Inclusion criteria: patients with mild-to-moderate AIS within 48 hours of symptom onset
Key exclusion criteria: clear indication for anticoagulation; history of intracerebral hemorrhage; planned for carotid revascularization; gastrointestinal or urinary tract bleeding in the last 3 months; allergy to clopidogrel or aspirin
Interventions
N=1502 dual antiplatelet therapy (clopidogrel 300 mg and aspirin 100 mg on day 1, followed by clopidogrel 75 mg and aspirin 100 mg on days 2-14 and clopidogrel 75 mg or aspirin 100 mg on days 15-90)
N=1413 aspirin alone (aspirin 100-300 mg on days 1-14, followed by aspirin 100 mg on days 15-90)
Primary outcome
Early neurologic deterioration at day 7
4.8
6.7
6.7 %
5.0 %
3.4 %
1.7 %
0.0 %
Dual antiplatelet therapy
Aspirin alone
Significant decrease ▼
NNT = 52
Significant decrease in early neurologic deterioration at day 7 (4.8% vs. 6.7%; RR 0.71, 95% CI 0.53 to 0.96)
Secondary outcomes
No significant difference in the rate of mRS score of 0-1 within 90 days (76.9% vs. 74.6%; RR 1.1, 95% CI 0.97 to 1.26)
No significant difference in the rate of new stroke within 90 days (0.8% vs. 1%; HR 0.84, 95% CI 0.39 to 1.85)
No significant difference in the rate of Other vascular events or death within 90 days (1.1% vs. 0.9%; HR 1.24, 95% CI 0.59 to 2.63)
Safety outcomes
No significant differences in bleeding events, adverse and serious adverse events.
Conclusion
In patients with mild-to-moderate AIS within 48 hours of symptom onset, dual antiplatelet therapy was superior to aspirin alone with respect to early neurologic deterioration at day 7.
Reference
Hui-Sheng Chen, Yu Cui, Xin-Hong Wang et al. Clopidogrel Plus Aspirin vs Aspirin Alone in Patients With Acute Mild to Moderate Stroke: The ATAMIS Randomized Clinical Trial. JAMA Neurol. 2024 Mar 11:e240146.
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