A Phase 4 interventional study of Intravenous GM1 Therapy and Placebo Therapy in Stroke and Acute Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Xuanwu Hospital, Beijing · Phase 4, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 868 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo Therapy
Drug: Intravenous GM1 Therapy
Patients should receive intravenous administration of GM1 as soon as possible after randomization (Highly recommend within 2 hours.) The GM1 group will receive 200mg daily until day 7 after randomization or hospital discharge by intravenous infusion (Qilu Pharmaceutical Co., Ltd., Jinan, China). GM1 will be dissolved in 100ml normal saline.
The control group will receive a placebo containing excipients only (without GM1). The placebo will be dissolved in normal saline and administered using the same methods, duration, and dosage regimen as the active treatment group. The appearance, preparation, and administration procedures of the placebo will be identical to those of the investigational drug to ensure blinding.
Rate of mRS score of 0-2
Time frame: 90 days (±7 days) after randomization
Rate of mRS score of 0-1
Time frame: 90 days (±7 days) after randomization
Rate of mRS score of 0-3
Time frame: 90 days (±7 days) after randomization
mRS scores (ordinal-shift analysis)
The modified Rankin Scale (mRS) is an ordinal scale ranging from 0 to 6 that measures the degree of disability or dependence in daily activities after stroke. Higher scores indicate greater disability. 0 No symptoms at all. 1. No significant disability despite symptoms; able to carry out all usual duties and activities. 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3. Moderate disability; requiring some help, but able to walk without assistance. 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. Dead.
Time frame: 90 days (±7 days) after randomization
NIHSS Score Change
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination scale used to quantify stroke-related neurological deficits and assess stroke severity. The NIHSS evaluates level of consciousness, gaze, visual fields, facial palsy, motor arm and leg function, limb ataxia, sensory function, language, dysarthria, and extinction/inattention. The total NIHSS score is calculated by summing the individual item scores and ranges from 0 to 42, with 0 indicating no neurological deficit and higher scores indicating greater stroke severity. 1a Level of Consciousness 0-3 1b Level of Consciousness Questions 0-2 1. c Level of Consciousness Commands 0-2 2. Best Gaze 0-2 3. Visual Fields 0-3 4. Facial Palsy 0-3 5. a Motor Arm, Left 0-4 5b Motor Arm, Right 0-4 6a Motor Leg, Left 0-4 6b Motor Leg, Right 0-4 7 Limb Ataxia 0-2 8 Sensory 0-2 9 Best Language 0-3 10 Dysarthria 0-2 11 Extinction and Inattention 0-2
Time frame: 48hours (±48 hours) after randomization
Rate of early neurological improvement
the NIHSS score 0-1 or decrease ≥4 from baseline NIHSS
Time frame: 48hours (±12 hours) after randomization
NIHSS Score Change
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination scale used to quantify stroke-related neurological deficits and assess stroke severity. The NIHSS evaluates level of consciousness, gaze, visual fields, facial palsy, motor arm and leg function, limb ataxia, sensory function, language, dysarthria, and extinction/inattention. The total NIHSS score is calculated by summing the individual item scores and ranges from 0 to 42, with 0 indicating no neurological deficit and higher scores indicating greater stroke severity. 1a Level of Consciousness 0-3 1b Level of Consciousness Questions 0-2 1. c Level of Consciousness Commands 0-2 2. Best Gaze 0-2 3. Visual Fields 0-3 4. Facial Palsy 0-3 5. a Motor Arm, Left 0-4 5b Motor Arm, Right 0-4 6a Motor Leg, Left 0-4 6b Motor Leg, Right 0-4 7 Limb Ataxia 0-2 8 Sensory 0-2 9 Best Language 0-3 10 Dysarthria 0-2 11 Extinction and Inattention 0-2
Time frame: 7 days after randomization or discharge
EQ-5D score
The EQ-5D-5L is a standardized measure of health-related quality of life developed by the EuroQol Group. It consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses across the five dimensions are combined into a 5-digit health state profile. The EQ VAS records the respondent's self-rated health on a vertical visual analogue scale, with endpoints anchored at 100 = the best health the respondent can imagine and 0 = the worst health the respondent can imagine. EQ-5D health states may be converted into a single index value using an appropriate EQ-5D value set, with higher index values indicating better health status.
Time frame: 90 days (±7 days) after randomization
Barthel Index
Time frame: 90 days (±7 days) after randomization
Rate of any ICH and subtypes
according to the Heidelberg Classification
Time frame: within 48 hours after randomization
Rate of sICH
according to the Heidelberg Definition
Time frame: within 48 hours after randomization
Mortality
Time frame: 90 days (±7 days) after randomization
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Xuanwu Hospital, Beijing