SE-GRACE
Trial question
What is the role of glyburide addition to thrombolytic therapy in patients with AIS?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 272
272 patients (78 female, 194 male).
Inclusion criteria: adult patients with AIS treated with rtPA.
Key exclusion criteria: previous ischemic stroke with significant disability; blood glucose < 3.0 mmol/L; known history of severe heart disease.
Interventions
N=142 glyburide (at an oral dose of 2.5 mg tablet).
N=130 placebo (matching placebo tablet).
Primary outcome
Modified Rankin Scale score 0-2 at day 90
73%
72%
73.0 %
54.8 %
36.5 %
18.3 %
0.0 %
Glyburide
Placebo
No significant
difference ↔
No significant difference in mRS score 0-2 at day 90 (73% vs. 72%; AD 1%, 95% CI -34.55 to 36.55).
Secondary outcomes
Borderline significant decrease in NIHSS score reduction ≥ 4 at day 7 (51% vs. 52%; RD -0.01, 95% CI -0.13 to 0.11).
Borderline significant decrease in parenchymal hemorrhagic transformation in cranial CT within 96 hours (12% vs. 10%; RD 0.026, 95% CI -0.04 to 0.09).
Borderline significant decrease in midline shift ≥ 6 mm in cranial CT within 96 hours (6% vs. 3%; RD 0.03, 95% CI -0.01 to 0.07).
Safety outcomes
No significant differences in death at day 90, adverse and serious adverse events.
Conclusion
In adult patients with AIS treated with rtPA, glyburide was not superior to placebo with respect to mRS score 0-2 at day 90.
Reference
Kaibin Huang, Xiaolin Zhao, Yunxiao Zhao et al. Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion / stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial. EClinicalMedicine. 2023 Nov 1:65:102305.
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