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NCT07626541Active, not recruitingPhase 2

Fructose for Acute Ischemic Stroke

Clinical Study of Fructose Injection in the Treatment of Acute Ischemic Stroke

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (actual)
First submitted
23 May 2026
Start date
5 Jun 2026
Primary completion date
Aug 2026
Lead sponsor
Ji Xunming,MD,PhD
Diseases
Stroke
NCT number
NCT07626541

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 46
  • From 5 Jun 2026 to the primary completion date, Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Requiring or intending to continue using restricted medications that may interfere with study safety and implementation.
  • Currently participating in another investigational drug or device study, or participation in other experimental treatment within less than 30 days prior to enrollment.

Other illness

  • History of fructose intolerance, abnormal fructose metabolism or hereditary fructose metabolic disorders.
  • Evidence of intracranial hemorrhage on CT scan, symptomatic intracranial hemorrhage, or clinical suspicion of subarachnoid hemorrhage.
  • Any other conditions judged by the investigator to be inappropriate for enrollment.
  • Pre-stroke mRS score ≥ 2, combined with dementia or other neurological disabling diseases.
  • 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.

Lab values

  • History of diabetes mellitus or random blood glucose \> 11.1 mmol/L.
  • 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.
  • Combined with severe hepatic and renal insufficiency (eGFR \< 30 mL/min/1.73m²).

Other

  • Unable to complete cranial MRI examination due to implanted metal materials, claustrophobia or other reasons.
  • Pregnant females.
  • Refusal to sign informed consent.

Who the study is looking for

  • Aged between 18 and 85 years, male and female are both eligible.
  • Clinical diagnosis of acute ischemic stroke meeting the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke.
  • Time from stroke onset to hospital admission ≤ 4.5 hours, with new ischemic lesions confirmed by emergency multimodal cranial MRI (DWI/T2WI).
  • Meeting the indications for intravenous thrombolysis, without absolute contraindications to thrombolysis, and planned to receive standard intravenous thrombolysis.
  • 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.
  • The patient or legal representative voluntarily participates in the study and signs written informed consent.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xuzhou Medical University Affiliated Hospital
Coordinator of this site? Confirm its status
XuzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.