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Tests treatment safety and results for Stroke
Official title Safety and Efficacy of Adjunctive GM1 to Mechanical Thrombectomy for Acute Anterior Circulation Large Vessel Occlusion
ClinicalTrials.gov ID: NCT07519044
What this study is testing
What is Intravenous GM1 Therapy?
Intravenous GM1 Therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 4.Acute ischemic stroke (AIS) selected for emergency endovascular treatment;
- 5.Premorbid mRS ≤1;
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shandong, Heze, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shandong, Heze, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.