A Phase 2/3 interventional study of Galantamine and Standard treatment for acute ischemic stroke in Acute Ischemic Stroke AIS, sponsored by Shanghai Yueyang Integrated Medicine Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Shanghai Yueyang Integrated Medicine Hospital · Phase 2/3, Interventional, and Treatment
Although mechanical thrombectomy or thrombolytic therapy for large vessels can achieve a revascularization rate (TICI ≥2b) of over 90%, 30-50% of patients still exhibit poor functional outcomes. This phenomenon of "ineffective reperfusion" suggests that microcirculatory dysfunction plays a decisive role in post-stroke neural injury. Therefore, it is necessary to combine brain protection strategies with microcirculatory reperfusion therapy to improve the functional prognosis of stroke patients.Increasing cerebral blood flow (CBF) and neurovascular unit (NVU)-based cerebral protection are current hotspots in the emergency treatment of stroke.
Galantamine, extracted from Lycoris aurea (a traditional Chinese medicinal herb), is an acetylcholinesterase inhibitor (AChEI) that has been widely recognized for improving cerebral blood flow and modulating inflammatory responses in ischemic stroke (IS).
Therefore, the applicant will conduct an internationally compliant, randomized controlled clinical study with routine treatment to evaluate the efficacy of galantamine in the treatment of acute cerebral infarction. This project will conduct a comprehensive assessment of the drug's efficacy from multiple aspects, including improvements in stroke-related outcomes, Traditional Chinese Medicine (TCM) syndrome manifestations, cognitive function, cerebral blood flow, and inflammatory factors.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 66 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Shanghai Yueyang Integrated Medicine Hospital is the lead sponsor of 38 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard treatment for acute ischemic stroke and galantamine
Drug: Galantamine · Drug: Standard treatment for acute ischemic stroke
Standard treatment for acute ischemic stroke
Drug: Standard treatment for acute ischemic stroke
Start within 24 hours of hospitalization, administer 5.0 mg of galantamine via intramuscular injection once daily, and continue the treatment for 10 days.
Also known as: Galantamine from Lycoris aurea extract
Standard treatment for acute ischemic stroke
Also known as: Routine Western medical treatment according to guidelines
The change in NIHSS score
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Scores assessed by Fugl-Meyer motor assessment (FMA)
Scores on the Fugl-Meyer motor assessment (FMA) range from 0 to 100,with lower scores indicating more severe the motor dysfunction
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Cerebral Blood Flow
The cerebral blood flow is evaluated by MRI
Time frame: Randomization Day,Day 30 (±4 days)
Fractional anisotropy (FA) values
The fractional anisotropy (FA) values is evaluated by MRI
Time frame: Randomization Day,Day 30 (±4 days)
TNF-α
Laboratory parameters obtained through venous blood analysis
Time frame: Randomization Day,Day 10 (±2 days)
IL-6
Laboratory parameters obtained through venous blood analysis
Time frame: Randomization Day,Day 10 (±2 days)
Modified Rankin Scale (mRS) score
The mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Scores assessed by Mini-Mental State Examination (MMSE)
The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Scores assessed by Montreal Cognitive Assessment (MoCA)
MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Traditional Chinese Medicine (TCM) syndrome manifestations
Under the guidance of Traditional Chinese Medicine (TCM) theory, evaluate the drug's effect on improving TCM syndrome manifestations (such as hemiplegia, deviated mouth and tongue, and speech impairment).
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
Barthel Index Score
It is used to measure the ability of patients (especially those with stroke, geriatric diseases, or in the rehabilitation period) to independently complete daily activities such as eating, dressing, walking, and using the toilet. The scoring range is 0-100 points, with higher scores indicating stronger self-care ability in daily life.
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
EQ-5D Scale Score
It is an internationally accepted assessment tool for "Health-Related Quality of Life (HRQoL)". Its core function is to quantitatively evaluate an individual's health status and quality of life through five dimensions: "mobility, self-care, usual activities, pain/discomfort, and anxiety/depression". It is widely used in clinical trials, health economics research, and chronic disease management (e.g., comprehensive evaluation of treatment effects in stroke patients).
Time frame: Randomization Day,Day 10 (±2 days),Day 30 (±4 days) and Day 90 (±7 days)
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Studies of the drug tested here: Galantamine
Shanghai Yueyang Integrated Medicine Hospital