Active, not recruiting
Phase 2
Fructose for Acute Ischemic Stroke
Condition(s) studied
Acute Ischemic Stroke
Investigational drug(s) / intervention(s)
10% Fructose Injection
10% Fructose Injection: Single intravenous infusion of 250 mL 10% fructose injection administered as early as possible within the ischemic stage, combined with standard intravenous thrombolysis and standardized basic treatment for acute ischemic stroke. Unified blood pressure and blood glucose management are implemented, and antiplatelet therapy is started 24 hours after thrombolysis.
Study summary
This is a single-center, prospective, randomized, open-label, blinded-endpoint exploratory clinical study enrolling 46 patients with acute ischemic stroke. All eligible patients have symptom onset within 4.5 hours, meet intravenous thrombolysis indications, and receive standard thrombolysis and routine stroke treatment. Participants are randomly assigned to two groups: the intervention group receives early intravenous infusion of 10% fructose injection plus standard treatment, while the control group receives only standard treatment without fructose. The study mainly evaluates changes in neurological function via NIHSS scores within 7 days after thrombolysis, assesses cerebral infarct lesion volume and brain edema using multimodal MRI including DWI, T2WI and MRS, detects cerebral neuronal metabolic markers, and conducts 1-month follow-up of neurological function by NIHSS score as well as functional prognosis using the mRS score. The research also comprehensively monitors adverse events and safety indicators to explore the clinical efficacy, neuronal metabolic regulation effect and safety of early fructose injection combined with intravenous thrombolysis in acute ischemic stroke patients, aiming to provide clinical evidence for early neuroprotective intervention.
Eligibility
Inclusion Criteria:
1. Aged between 18 and 85 years, male and female are both eligible.
2. Clinical diagnosis of acute ischemic stroke meeting the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke.
3. Time from stroke onset to hospital admission ≤ 4.5 hours, with new ischemic lesions confirmed by emergency multimodal cranial MRI (DWI/T2WI).
4. Meeting the indications for intravenous thrombolysis, without absolute contraindications to thrombolysis, and planned to receive standard intravenous thrombolysis.
5. Relatively stable vital signs, able to complete baseline and follow-up cranial MRI examinations including DWI, T2WI and ¹H-MRS, as well as NIHSS and mRS scale assessments.
6. The patient or legal representative voluntarily participates in the study and signs written informed consent.
Exclusion Criteria:
1. History of fructose intolerance, abnormal fructose metabolism or hereditary fructose metabolic disorders.
2. History of diabetes mellitus or random blood glucose \> 11.1 mmol/L.
3. Evidence of intracranial hemorrhage on CT scan, symptomatic intracranial hemorrhage, or clinical suspicion of subarachnoid hemorrhage.
4. Requiring or intending to continue using restricted medications that may interfere with study safety and implementation.
5. Unable to complete cranial MRI examination due to implanted metal materials, claustrophobia or other reasons.
6. Any other conditions judged by the investigator to be inappropriate for enrollment.
7. Presence of hemorrhagic diathesis, including but not limited to:
* Known hereditary bleeding tendency or severe bleeding disease within the past 6 months;
* Received heparin within 48 hours before enrollment with aPTT exceeding the upper limit of laboratory reference range;
* Current use of vitamin K-dependent oral anticoagulants with INR \> 1.7 or PT \> 15 s, or current use of novel oral anticoagulants with prolonged aPTT/PT above laboratory upper limit;
* Platelet count \< 100,000/mm³ at screening;
* History of central nervous system diseases such as tumor, aneurysm, intracranial or spinal surgery;
* Received traumatic closed-chest cardiac massage, obstetric delivery or non-compressible vascular puncture within the past 10 days;
* Suspected intracranial hemorrhage or aneurysmal subarachnoid hemorrhage;
* Tumors with increased bleeding risk;
* Peptic ulcer disease, esophageal varices, aneurysm, arterial/venous malformation within the past 3 months;
* Any other known diseases associated with significantly elevated bleeding risk.
8. Pre-stroke mRS score ≥ 2, combined with dementia or other neurological disabling diseases.
9. Complicated with severe medical history affecting endpoint evaluation and follow-up, such as craniocerebral trauma, multiple sclerosis, encephalitis, tumor, poisoning, syphilis, or severe cardiac, pulmonary, hepatic, renal and endocrine diseases.
10. Pregnant females.
11. Currently participating in another investigational drug or device study, or participation in other experimental treatment within less than 30 days prior to enrollment.
12. Combined with severe hepatic and renal insufficiency (eGFR \< 30 mL/min/1.73m²).
13. Refusal to sign informed consent.
Primary outcome measure(s)
- 7-day change in National Institutes of Health Stroke Scale (NIHSS) score — Baseline to 7 days after thrombolysis
Absolute change in NIHSS score, calculated as follow-up score minus pre-intravenous thrombolysis (pre-IVT) baseline score, assessed at 7 days after intravenous thrombolysis (IVT). The full scale is the National Institutes of Health Stroke Scale; total score ranges from 0 to 42, and higher scores indicate more severe neurological deficits.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Xuzhou Medical University Affiliated Hospital |
Xuzhou |
Jiangsu |
|
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