Abstract Body: Introduction：Glucagon-like peptide-1 (GLP-1) receptor agonists have demonstrated the effect of reducing the risk of cardiovascular events in patients with type 2 diabetes (T2DM). However, there is a lack of clinical trials to evaluate their potential for decreasing stroke recurrence in acute ischemic stroke.
Hypothesis：GLP-1 receptor agonist liraglutide may improve the risk of stroke and prognosis in acute minor ischemic stroke or high-risk TIA patients with T2DM.
Methods：The LAMP trial was designed as a prospective, multicenter, randomized, blank-controlled, parallel-group, open-label, blinded end point trial at 27 medical centres in China. Acute minor ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score≤3) or high-risk TIA (ABCD2 score ≥4) patients with T2DM were recruited between June 25, 2019 and December 27, 2023. The primary outcome was new stroke (ischemic or hemorrhagic stroke) within 90 days. Safety end points included symptomatic intracranial hemorrhage (sICH) and all-cause mortality at 90 days.
Results：A total of 928 patients were screened and 636 patients were included in the full analysis set. Among them, the liraglutide group (317 patients) receives standard treatment plus liraglutide, while the control group (319 patients) receives standard treatment. Within 90 days, 25 patients (7.9%) in the liraglutide group and 44 patients (13.8%) in the control group experienced a new stroke (HR: 0.56, 95%CI: 0.34-0.91, P=0.02). The proportion of patients achieving an excellent functional outcome (mRS≤1) in the liraglutide group (87.3%) was significantly higher compared to the control group (77.8%) (OR: 1.95; 95%CI:1.28-3.00; P=0.002). Symptomatic intracranial hemorrhage occurred in 0.3% of patients in the liraglutide group and 0.6% of patients in the control group, while mortality rates were 0.3% and 1.3%, respectively (P values: 0.5 and 0.1).
Conclusions：Among Chinese patients with acute minor ischemic stroke or high-risk TIA who were diagnosed with T2DM, treatment with liraglutide reduces the risk of stroke and improves prognosis at 90 days, without increasing the risk of sICH and mortality. Findings from this study support the use of liraglutide as a favorable option setting. ClinicalTrials.gov identifier: NCT03948347
Funded by the Science and Technology Program of Guangzhou (202002020003, 202201020070, and 2023A03J1023).