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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Therapy | Placebo Comparator |
| |
| Intravenous GM1 Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous GM1 Therapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of mRS score of 0-2 | 90 days (±7 days) after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of mRS score of 0-1 | 90 days (±7 days) after randomization | |
| Rate of mRS score of 0-3 | 90 days (±7 days) after randomization | |
| mRS scores (ordinal-shift analysis) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of any ICH and subtypes | according to the Heidelberg Classification | within 48 hours after randomization |
| Rate of sICH | according to the Heidelberg Definition |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuesong Bai | Contact | Xuanwu Hospital | bxsben@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University. | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Placebo Therapy | Drug | 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. |
|
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.
|
| 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
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 | 48hours (±48 hours) after randomization |
| Rate of early neurological improvement | the NIHSS score 0-1 or decrease ≥4 from baseline NIHSS | 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
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 | 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. | 90 days (±7 days) after randomization |
| Barthel Index | 90 days (±7 days) after randomization |
| within 48 hours after randomization |
| Mortality | 90 days (±7 days) after randomization |
| Heze Municipal Hospital | Recruiting | Shandong | Heze | China |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |