TREND
Trial question
What is the role of intravenous tirofiban in patients with acute noncardioembolic stroke?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 425
425 patients (124 female, 301 male).
Inclusion criteria: adult patients, 18-80 years, with acute noncardioembolic stroke within 24 hours of onset who had a NIHSS score of 4-20.
Key exclusion criteria: treated with IV or endovascular thrombectomy for the index AIS; AIS caused by determined or suspected cardioembolism; AIS caused by other determined causes; allergy to tirofiban or its solvents; known hematochezia, gastrointestinal bleeding, or any other bleeding.
Interventions
N=213 intravenous tirofiban (at 0.4 mcg/kg/min for 30 minutes, followed by 0.1 mcg/kg/min for 72 hours with transition to oral aspirin).
N=212 oral aspirin (at a dose of 100-300 mg daily).
Primary outcome
Early neurological deterioration within 72 hours
4.2%
13.2%
13.2 %
9.9 %
6.6 %
3.3 %
0.0 %
Intravenous
tirofiban
Oral
aspirin
Significant
decrease ▼
NNT = 11
Significant decrease in early neurological deterioration within 72 hours (4.2% vs. 13.2%; RR 0.32, 95% CI 0.16 to 0.65).
Secondary outcomes
Significant decrease in worsening of NIHSS score by ≥ 2 points within 72 hours (11.7% vs. 23.6%; RR 0.49, 95% CI 0.32 to 0.75).
No significant difference in median mRS score at day 90 (1 point vs. 1 point; OR 1.28, 95% CI 0.9 to 1.83).
No significant difference in early improvement of NIHSS score by ≥ 4 points (13.1% vs. 13.2%; RR 1.13, 95% CI 0.7 to 1.18).
Safety outcomes
No significant differences in serious adverse events, including intracerebral hemorrhage and systematic bleeding, or death.
Conclusion
In adult patients, 18-80 years, with acute noncardioembolic stroke within 24 hours of onset who had a NIHSS score of 4-20, intravenous tirofiban was superior to oral aspirin with respect to early neurological deterioration within 72 hours.
Reference
Wenbo Zhao, Sijie Li, Chuanhui Li et al. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602.
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