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

NCT07519044 | Recruiting Phase 4 DMC

• 1 other identifier: IAT-GIANT
• Study Type: interventional
• Target: 868
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

GM1; Mechanical Thrombectomy; Acute Anterior Circulation Large Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

• Rate of mRS score of 0-2

  90 days (±7 days) after randomization

Secondary Outcomes (8)

• 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)

  90 days (±7 days) after randomization

• NIHSS Score Change

  48hours (±48 hours) after randomization

• Rate of early neurological improvement

  48hours (±12 hours) after randomization

Other Outcomes (3)

• Rate of any ICH and subtypes

  within 48 hours after randomization

• Rate of sICH

  within 48 hours after randomization

• Mortality

  90 days (±7 days) after randomization

Study Arms (2)

Placebo Therapy

PLACEBO COMPARATOR

Drug: Placebo Therapy

Intravenous GM1 Therapy

EXPERIMENTAL

Drug: Intravenous GM1 Therapy

Interventions

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.

Placebo Therapy

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.

Intravenous GM1 Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤80 years
• Symptoms and signs consistent with anterior circulation ischemia;
• 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);
• Acute ischemic stroke (AIS) selected for emergency endovascular treatment;
• Premorbid mRS ≤1;
• 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);
• National Institutes of Health Stroke Score (NIHSS) ≥6 at admission;
• ASPECTS ≥3;
• Informed consent obtained from the patient or his/her legal representative.

You may not qualify if:

• Simultaneous acute occlusion of large vessels in both the anterior and posterior circulation or bilateral cerebral hemispheres.
• Baseline NIHSS is not obtained by a neurologist or emergency physician prior to sedation or intubation;
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS;
• Bilateral dilated pupils;
• Allergy to GM1 or excipients;
• Severe contrast allergy or absolute contraindication to iodinated contrast;
• Systolic pressure \>185 mmHg or diastolic pressure \>110 mmHg, and cannot be controlled by antihypertensive drugs;
• Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L);
• Platelet \<50\*10\^9/L;
• 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;
• 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;
• Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.);
• Presumed vasculitis or septic embolization;
• Suspicion of aortic dissection;
• Evidence indicates intracranial tumors (excluding small meningiomas), acute intracranial hemorrhage, tumors, or arteriovenous malformations (AVMs).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Heze Municipal Hospital

Shandong, Heze, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xuesong Bai

CONTACT

Xuanwu Hospital; bxsben@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)