TEXAIS
Trial question
What is the role of exenatide in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 346
346 patients (105 female, 241 male).
Inclusion criteria: adult patients with AIS ≤ 9 hours of stroke onset.
Key exclusion criteria: known allergy/hypersensitivity to exenatide; receipt of other glucose-like peptide-1 receptor agonists; history of active pancreatitis; impaired renal function.
Interventions
N=174 exenatide (a subcutaneous injection of 5 mcg BID for 5 days or until hospital discharge).
N=172 standard care (stroke unit care as per local hospital protocols).
Primary outcome
≥ 8-point improvement in National Institutes of Health Stroke Scale score at 7 days poststroke
61.2%
56.7%
61.2 %
45.9 %
30.6 %
15.3 %
0.0 %
Exenatide
Standard
care
No significant
difference ↔
No significant difference in ≥ 8-point improvement in NIHSS score at 7 days poststroke (61.2% vs. 56.7%; OR 1.22, 95% CI 0.79 to 1.88).
Secondary outcomes
No significant difference in mRS scores 0-2 at day 90 (74% vs. 74.7%; OR 0.96, 96% CI 0.56 to 1.66).
No significant difference in median National Institute of Health Stroke Scale score at day 90 (0 points vs. 1 points; AD -1 points, 95% CI -2.73 to 0.73).
Borderline significant increase in median difference in National Institute of Health Stroke Scale score between baseline and day 90 (3 points vs. 3 points).
Safety outcomes
No significant difference in death and serious adverse events at day 90.
Significant difference in at least 1 episode of nausea and vomiting (3.5% vs. 0%) and adverse event (36.2% vs. 26.2%) over treatment period.
Conclusion
In adult patients with AIS ≤ 9 hours of stroke onset, exenatide was not superior to standard care with respect to ≥ 8-point improvement in NIHSS score at 7 days poststroke.
Reference
Christopher F Bladin, Ngai Wah Cheung, Helen M Dewey et al. Management of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial. Stroke. 2023 Dec;54(12):2962-2971.
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