ARAMIS
Trial question
Is dual antiplatelet therapy noninferior to alteplase in patients with minor non-disabling AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 719
719 patients (223 female, 496 male)
Inclusion criteria: patients with minor non-disabling AIS presenting within 4.5 hours of symptom onset
Key exclusion criteria: prestroke disability; history of intracerebral hemorrhage; definite indication for anticoagulation
Interventions
N=369 dual antiplatelet therapy (loading dose of clopidogrel and aspirin, followed by daily doses and guideline-based antiplatelet treatment)
N=350 alteplase (intravenous alteplase 0.9 mg/kg, followed by guideline-based antiplatelet treatment)
Primary outcome
Excellent functional outcome at day 90
93.8
91.4
93.8 %
70.3 %
46.9 %
23.4 %
0.0 %
Dual antiplatelet therapy
Alteplase
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in excellent functional outcome at day 90 (93.8% vs. 91.4%; AD 2.3%, 95% CI -1.5 to 6.2)
Secondary outcomes
No significant difference in mRS score of 0-2 at day 90 (95.9% vs. 95.4%; RR 1.12, 95% CI 0.56 to 2.24)
Significant decrease in early neurological deterioration within 24 hours (4.6% vs. 9.1%; RR 0.5, 95% CI 0.29 to 0.89)
No significant difference in death at day 90 (0.5% vs. 0.9%; RR 0.63, 95% CI 0.11 to 3.76)
Safety outcomes
No significant difference in symptomatic intracerebral hemorrhage.
Significant difference in any bleeding events (1.6% vs. 5.4%).
Conclusion
In patients with minor non-disabling AIS presenting within 4.5 hours of symptom onset, dual antiplatelet therapy was noninferior to alteplase with respect to excellent functional outcome at day 90.
Reference
Hui-Sheng Chen, Yu Cui, Zhong-He Zhou et al. Dual Antiplatelet Therapy vs Alteplase for Patients With Minor Nondisabling Acute Ischemic Stroke: The ARAMIS Randomized Clinical Trial. JAMA. 2023 Jun 27;329(24):2135-2144.
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