Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion

Stroke is a leading cause of global mortality and morbidity, with acute ischemic stroke (AIS) accounting for approximately 65.3% of cases and resulting in roughly 3.4 million new cases annually in China. While endovascular thrombectomy (EVT) is the recommended first-line therapy for large vessel occlusion (LVO), achieving 80-90% recanalization, fewer than 50% of patients reach functional independence (mRS 0-2) due to "futile recanalization" caused by mechanisms like no-reflow and reperfusion injury. Monosialotetrahexosylganglioside (GM1) is a unique glycosphingolipid that crosses the blood-brain barrier to provide neuroprotection by suppressing oxidative stress, excitotoxicity, and apoptosis while promoting neurogenesis. Although Phase III trials like the FOCUS study confirmed GM1's safety and efficacy in AIS populations, its benefit specifically for patients undergoing mechanical thrombectomy remains unkown. Therefore, the IAT-GIANT study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of adjunctive GM1 in improving 90-day functional outcomes for AIS-LVO patients treated with EVT.

NCT Number	NCT07519044
Lead Sponsor	Xuanwu Hospital, Beijing
Conditions	Stroke, Acute Ischemic Stroke
Enrollment	868 participants
Start Date	2026-05-14
Primary Completion	2027-01-31 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-24