Clinical Trial

Fructose for Acute Ischemic Stroke

Study acronym: FRUCTOSE-AIS
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-06-19
Trial Details
NCT Number NCT07626541
Lead Sponsor Ji Xunming,MD,PhD
Conditions Acute Ischemic Stroke
Enrollment 46 participants
Start Date 2026-06-05
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-18