ARAIS
Trial question
What is the role of argatroban plus intravenous alteplase in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.1% female
70.9% male
N = 696
696 patients (238 female, 579 male)
Inclusion criteria: adult patients with AIS who were assigned within 4.5 hours of symptom onset
Key exclusion criteria: presence of disability in the community before the stroke; history of intracerebral hemorrhage; gastrointestinal or urinary tract bleeding in the last 30 days; need for concomitant use of anticoagulants other than argatroban
Interventions
N=329 argatroban plus alteplase (intravenous argatroban within 1 hour after intravenous alteplase)
N=367 alteplase alone (intravenous alteplase)
Primary outcome
Excellent functional outcome at day 90
63.8
64.9
64.9 %
48.7 %
32.5 %
16.2 %
0.0 %
Argatroban plus alteplase
Alteplase alone
No significant difference ↔
No significant difference in excellent functional outcome at day 90 (63.8% vs. 64.9%; RR 0.98, 95% CI 0.88 to 1.1)
Secondary outcomes
No significant difference in mRS score of 0-2 within 90 (76% vs. 76.3%; RR 1, 95% CI 0.92 to 1.08)
No significant difference in early neurologic improvement within 48 hours (69% vs. 67.9%; RR 1.03, 95% CI 0.84 to 1.27)
No significant difference in early neurologic deterioration within 48 hours (3.6% vs. 5.1%; RR 0.71, 95% CI 0.36 to 1.4)
Safety outcomes
No significant difference in symptomatic ICH; parenchymal hematoma type 2; major systemic bleeding.
Conclusion
In adult patients with AIS who were assigned within 4.5 hours of symptom onset, argatroban plus alteplase was not superior to alteplase alone with respect to excellent functional outcome at day 90.
Reference
Hui-Sheng Chen, Yu Cui, Zhong-He Zhou et al. Effect of Argatroban Plus Intravenous Alteplase vs Intravenous Alteplase Alone on Neurologic Function in Patients With Acute Ischemic Stroke: The ARAIS Randomized Clinical Trial. JAMA. 2023 Feb 9;e230550.
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