EASE
Trial question
What is the role of argatroban in patients with AIS and early neurological deterioration?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 628
628 patients (228 female, 400 male).
Inclusion criteria: patients with AIS and early neurological deterioration.
Key exclusion criteria: cardiogenic cerebral embolism; National Institute of Health Stroke Scale score ≥ 21; conversion of ICH; BP ≥ 180/110 mmHg after treatment; hematological diseases and those with bleeding tendency.
Interventions
N=314 argatroban (continuous infusion with a dose of 60 mg/day for 2 days followed by a dose of 20 mg/day for 5 days plus standard therapy).
N=314 standard therapy (standard guideline treatment alone).
Primary outcome
Modified Rankin Scale score < 4 at day 90
80.5%
73.3%
80.5 %
60.4 %
40.3 %
20.1 %
0.0 %
Argatroban
Standard
therapy
Significant
increase ▲
NNT = 13
Significant increase in mRS score < 4 at day 90 (80.5% vs. 73.3%; RR 1.1, 95% CI 1.01 to 1.2).
Secondary outcomes
No significant difference in mRS score of 0-2 at day 90 (55.7% vs. 50.2%; RR 1.11, 95% CI 0.96 to 1.29).
No significant difference in National Institute of Health Stroke Scale score at day 90 (2 points vs. 2 points; MD -0.74, 95% CI -2.64 to 1.15).
No significant difference in Barthel scale score at day 90 (90 points vs. 90 points; MD 4.69, 95% CI -0.5 to 9.86).
Safety outcomes
No significant differences in symptomatic ICH, parenchymal hematoma, other bleeding events.
Conclusion
In patients with AIS and early neurological deterioration, argatroban was superior to standard therapy with respect to mRS score < 4 at day 90.
Reference
Xuting Zhang, Wansi Zhong, Rui Xue et al. Argatroban in Patients With Acute Ischemic Stroke With Early Neurological Deterioration: A Randomized Clinical Trial. JAMA Neurol. 2024 Feb 1;81(2):118-125.
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