GM1 added to mechanical thrombectomy for large vessel stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, Phase 4 trial examines whether intravenous GM1 as an adjunct to endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion. Participants are adults 18–80 who are treated for AIS with emergency thrombectomy and have favorable premorbid function, with specific imaging-confirmed occlusions and moderate stroke severity. The study compares GM1 to placebo, aiming to reduce futile recanalization and enhance neuroprotection during reperfusion. Primary and secondary outcomes evaluate functional independence and safety in the post-thrombectomy period. The trial is conducted at Xuanwu Hospital and Heze Municipal Hospital, with lead sponsor Xuanwu Hospital, Capital Medical University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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);
* 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.

Exclusion Criteria:

* 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;
* 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.

Where it's running

• Xuanwu Hospital, Capital Medical University.
  Beijing, Beijing Municipality, China Recruiting
• Heze Municipal Hospital
  Shandong, Heze, China Recruiting

Study contacts

• Study coordinator: Xuesong Bai
• Email: bxsben@163.com
• Phone: Xuanwu Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.