BAST
Trial question
What is the effect of butylphthalide in patients with AIS?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
32.0% female
68.0% male
N = 1216
1216 patients (389 female, 827 male)
Inclusion criteria: adult patients with AIS receiving intravenous thrombolysis and/or endovascular treatment
Key exclusion criteria: mRS score > 1 at randomization; ASPECTS score ≤ 6 confirmed by preoperational CT scan; intracranial hemorrhagic disease; receipt of butylphthalide or any drug containing butylphthalide between onset and randomization
Interventions
N=607 butylphthalide (intravenous dose of 25 mg BID for 14 days, followed by oral dose of 0.2 g TID from day 15-90)
N=609 placebo (matching intravenous placebo, followed by oral placebo for 90 days)
Primary outcome
Favorable modified Rankin Scale score at day 90
56.7
44
56.7 %
42.5 %
28.4 %
14.2 %
0.0 %
Butylphthalide
Placebo
Significant
increase ▲
NNT = 7
Significant increase in favorable mRS score at day 90 (56.7% vs. 44%; OR 1.7, 95% CI 1.35 to 2.14)
Secondary outcomes
Significant increase in median reduction in NIHSS score at day 90 (6 points vs. 5 points; MD 1, 95% CI 0 to 1)
No significant difference in median cerebral infarction volume on day 14 (2.8 mL vs. 3.7 mL; MD -0.23, 95% CI -0.71 to 0.11)
No significant difference in symptomatic ICH within the first 24 hours (1.3% vs. 1.1%; OR 1.17, 95% CI 0.42 to 3.24)
Safety outcomes
No significant differences in adverse and serious adverse events, symptomatic ICH, death.
Conclusion
In adult patients with AIS receiving intravenous thrombolysis and/or endovascular treatment, butylphthalide was superior to placebo with respect to favorable mRS score at day 90.
Reference
Anxin Wang, Baixue Jia, Xuelei Zhang et al. Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Aug 1;80(8):851-859.
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