Fructose for Acute Ischemic Stroke (FRUCTOSE-AIS)

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.