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Tests treatment safety and results for Acute Ischemic Stroke AIS
Official title Exploration of the Efficacy and Mechanism of Galantamine (an Extract From Lycoris Aurea) in Treating Ischemic Stroke
ClinicalTrials.gov ID: NCT07003386
What this study is testing
What is Galantamine?
Galantamine is an investigational medicine, given as an once-daily injection into a muscle, being studied as a potential treatment for acute ischemic stroke ais.
Also referred to as Galantamine from Lycoris aurea extract.
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
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 85
You may be able to join if
- Aged \> 18 years and \< 85 years, regardless of gender
- Meeting the diagnostic criteria for ischemic stroke in Western medicine
- Meeting the diagnostic criteria for stroke (Zhongfeng) in Traditional Chinese Medicine (TCM)
- Diagnosis of acute ischemic stroke within 72h of symptom onset
- A score of 4-25 points on the National Institute of Health Stroke Scale (NIHSS)
You likely can't join if
- Confirmed by cranial imaging examination to have diseases causing similar symptoms such as brain tumors, encephalitis, and brain abscesses; or...
- Patients with severe abnormalities of liver and kidney function (liver function: alanine aminotransferase [ALT] \>2 times the upper limit of normal...
- Elderly patients with physical weakness or patients complicated with infection
- Patients with a history of mental illness or dementia
- Patients with other severe organ or systemic diseases, accompanied by malignant tumors in any organ or system, or undergoing anti-tumor treatment...
- A significant history of drug or alcohol abuse
See the full eligibility criteria
- Aged \> 18 years and \< 85 years, regardless of gender
- Meeting the diagnostic criteria for ischemic stroke in Western medicine
- Meeting the diagnostic criteria for stroke (Zhongfeng) in Traditional Chinese Medicine (TCM)
- Diagnosis of acute ischemic stroke within 72h of symptom onset
- A score of 4-25 points on the National Institute of Health Stroke Scale (NIHSS)
- First onset of the disease, or no severe sequelae related to previous onset
- The patient and their legal guardian voluntarily sign the informed consent form for the study
- Confirmed by cranial imaging examination to have diseases causing similar symptoms such as brain tumors, encephalitis, and brain abscesses; or confirmed to have hemorrhagic cerebral infarction,epidural...
- Patients with severe abnormalities of liver and kidney function (liver function: alanine aminotransferase [ALT] \>2 times the upper limit of normal [ULN]; renal function: creatinine [Cr]\>1.5 times the upper limit of...
- Elderly patients with physical weakness or patients complicated with infection
- Patients with a history of mental illness or dementia
- Patients with other severe organ or systemic diseases, accompanied by malignant tumors in any organ or system, or undergoing anti-tumor treatment, with an expected survival time of \< 6 months
- A significant history of drug or alcohol abuse
- Women who test positive for blood human chorionic gonadotropin (HCG) (i.e., HCG ≥ 5 mIU/mL) during pregnancy screening, plan to become pregnant during the trial, or are breastfeeding
- Patients who are currently participating in other clinical trials or have participated in other clinical trials within the past 1 month
- Patients who are currently using other cholinesterase inhibitor drugs or have used other cholinesterase inhibitor drugs within the past 3 months
- Patients with epilepsy, hyperkinesis, mechanical intestinal obstruction, bronchial asthma, angina pectoris, bradycardia, or glaucoma
- Patients with contraindications to brain magnetic resonance imaging (MRI) examination, such as patients with implanted cardiac pacemakers, patients with implanted artificial joints or orthopedic plates, patients with...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.