StrokePhase 4IAT-GIANTNCT07519044
Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion
A Phase 4 study testing Intravenous GM1 Therapy in people with Stroke and Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute Ischemic Stroke
- What is being tested?
- Intravenous GM1 Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 868 participants
- Where
- 2 sitesChina
- Study dates
- 14 May 2026to 31 Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age ≥18 years and ≤80 years
- 2.Symptoms and signs consistent with anterior circulation ischemia;
- 3.Computed tomography angiography (CTA) /magnetic resonance angiography (MRA) /digital subtraction angiography (DSA) confirmed occlusion of intracranial segment of internal carotid artery (ICA) or M1/M2 segments of the middle cerebral artery (MCA M1/M2);
- 4.Acute ischemic stroke (AIS) selected for emergency endovascular treatment;
- 5.Premorbid mRS ≤1;
- 6.Time from symptom onset to randomization was within 24 hours, including patients with wake-up stroke or unwitnessed stroke; The time of symptom onset was defined as the Last Known Well (LKW);
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- 7.National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
- 8.ASPECTS ≥3;
- 9.Informed consent obtained from the patient or his/her legal representative.
Who cannot join
- 1.Simultaneous acute occlusion of large vessels in both the anterior and posterior circulation or bilateral cerebral hemispheres.
- 2.Baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation;
- 3.Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
- 4.Bilateral dilated pupils;
- 5.Allergy to GM1 or excipients;
- 6.Severe contrast allergy or absolute contraindication to iodinated contrast;
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- 7.Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs;
- 8.Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L);
- 9.Platelet <50*10^9/L;
- 10.Known genetic or acquired bleeding diathesis, deficiency of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
- 11.Known Severe renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) <30, or patient requires hemodialysis or peritoneal dialysis;
- 12.Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.);
- 13.Presumed vasculitis or septic embolization;
- 14.Suspicion of aortic dissection;
- 15.Evidence indicates intracranial tumors (excluding small meningiomas), acute intracranial hemorrhage, tumors, or arteriovenous malformations (AVMs).
- 16. Significant mass effect causing midline shift.
- 17. The patient has neurological disease or mental disorder before onset, which affects the assessment of the condition;
- 18.Females who are pregnant or in lactation;
- 19.Hereditary glycolipid metabolic disorders (ganglioside storage diseases, such as familial amaurotic idiocy, retinal degenerative diseases);
- 20.Autoimmune diseases, spine injuries, demyelinating diseases (e.g., Guillain-Barre syndrome)
- 21.Participating in other clinical trials that could confound the evaluation of the study;
- 22.Other circumstances that the investigator considers inappropriate for participation or may pose a significant risk to patients.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing, Beijing Municipality
Liqun Jiao, Dr., +86 13911224991, liqunjiao@sina.cn
- Recruiting
Heze Municipal Hospital
Shandong, Heze
Kai Li, MD., +86-18661581160, 18661581160.bz0508@126.com
About this study
Official title: Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study-IAT-GIANT (Ganglioside GM1 to Improve Outcomes in Anterior CirculatioN Thrombectomy)
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.
- Conditions
- Stroke, Acute Ischemic Stroke
- Being tested
- Intravenous GM1 Therapy, Placebo Therapy
- Keywords
- GM1, Mechanical Thrombectomy, Acute Anterior Circulation Large Vessel Occlusion
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous GM1 TherapyDrug
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.
Placebo TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Therapy | Placebo comparator | Not described Receives: Drug: Placebo Therapy |
| Intravenous GM1 Therapy | Experimental | Not described Receives: Drug: Intravenous GM1 Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mRS score of 0-2
Measured: 90 days (±7 days) after randomization
Secondary outcomes (8)
Rate of mRS score of 0-1
Measured: 90 days (±7 days) after randomization
Rate of mRS score of 0-3
Measured: 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.
- No significant disability despite symptoms; able to carry out all usual duties and activities.
- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.
- Moderate disability; requiring some help, but able to walk without assistance.
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
- Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
- Dead.
Measured: 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
- c Level of Consciousness Commands 0-2
- Best Gaze 0-2
- Visual Fields 0-3
- Facial Palsy 0-3
- 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
Measured: 48hours (±48 hours) after randomization
Rate of early neurological improvement
the NIHSS score 0-1 or decrease ≥4 from baseline NIHSS
Measured: 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
- c Level of Consciousness Commands 0-2
- Best Gaze 0-2
- Visual Fields 0-3
- Facial Palsy 0-3
- 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
Measured: 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.
Measured: 90 days (±7 days) after randomization
Barthel Index
Measured: 90 days (±7 days) after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start14 May 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519044
- Sponsor's protocol ID
- IAT-GIANT
- Acronym
- IAT-GIANT
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study-IAT-GIANT (Ganglioside GM1 to Improve Outcomes in Anterior CirculatioN Thrombectomy)
- ClinicalTrials.gov ID
- NCT07519044
- Acronym / sponsor ID
- IAT-GIANT / IAT-GIANT
- Conditions
- Stroke, Acute Ischemic Stroke
- Keywords
- GM1, Mechanical Thrombectomy, Acute Anterior Circulation Large Vessel Occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 868 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Therapy | Placebo comparator | Drug: Placebo Therapy |
| Intravenous GM1 Therapy | Experimental | Drug: Intravenous GM1 Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Age ≥18 years and ≤80 years
- 2.Symptoms and signs consistent with anterior circulation ischemia;
- 3.Computed tomography angiography (CTA) /magnetic resonance angiography (MRA) /digital subtraction angiography (DSA) confirmed occlusion of intracranial segment of internal carotid artery (ICA) or M1/M2 segments of the middle cerebral artery (MCA M1/M2);
- 4.Acute ischemic stroke (AIS) selected for emergency endovascular treatment;
- 5.Premorbid mRS ≤1;
Key exclusion criteria (22 listed)
- 1.Simultaneous acute occlusion of large vessels in both the anterior and posterior circulation or bilateral cerebral hemispheres.
- 2.Baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation;
- 3.Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
- 4.Bilateral dilated pupils;
- 5.Allergy to GM1 or excipients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous GM1 TherapyPatients 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. | Drug | Intravenous GM1 Therapy |
| Placebo TherapyThe 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. | Drug | Placebo Therapy |
Primary outcome
Rate of mRS score of 0-2
Time frame: 90 days (±7 days) after randomization
8 secondary outcomes
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)
Time frame: 90 days (±7 days) after randomization
NIHSS Score Change
Time frame: 48hours (±48 hours) after randomization
Rate of early neurological improvement
Time frame: 48hours (±12 hours) after randomization
NIHSS Score Change
Time frame: 7 days after randomization or discharge
EQ-5D score
Time frame: 90 days (±7 days) after randomization
Barthel Index
Time frame: 90 days (±7 days) after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous GM1 Therapy in people with Stroke and Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuesong Bai (Xuanwu Hospital, bxsben@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mRS score of 0-2 (time frame: 90 days (±7 days) after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.