A Phase 2 interventional study of 10% Fructose Injection in Acute Ischemic Stroke, sponsored by Ji Xunming,MD,PhD. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Ji Xunming,MD,PhD · Phase 2, Interventional, and Treatment
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.
This is an investigator-initiated, single-center, prospective, randomized, open-label, blinded-endpoint (PROBE) exploratory clinical trial. A total of 46 eligible patients with acute ischemic stroke within 4.5 hours of onset who meet the indications for intravenous thrombolysis will be enrolled. Participants are randomly assigned to an intervention group and a control group.The intervention group receives early intravenous infusion of 250 mL 10% fructose injection combined with standard intravenous thrombolysis and routine stroke background treatment. The control group receives only standard intravenous thrombolysis and conventional medical therapy without fructose intervention. All patients undergo standardized blood pressure and blood glucose management, and antiplatelet therapy is initiated 24 hours after thrombolysis.Neurological function is repeatedly assessed using the National Institutes of Health Stroke Scale (NIHSS) every 12 hours within 72 hours after thrombolysis and daily thereafter. Multimodal brain magnetic resonance examinations including DWI, T2WI and MRS are performed to evaluate cerebral infarct lesion volume, cerebral edema, and neuronal metabolic biomarkers such as NAA, Cho and Lac. The primary outcome is the change in NIHSS score at 7 days after thrombolysis, and cerebral neuronal metabolic characteristics. Secondary outcomes include dynamic neurological recovery, imaging changes of ischemic lesions, 1-month NIHSS score, 1-month modified Rankin Scale (mRS) functional prognosis.Prespecified subgroup analyses are conducted according to baseline neurological deficit severity, age, hypertension history and gender. Safety outcomes monitor adverse events such as hemorrhagic transformation, allergic reactions, liver and renal function abnormalities, blood glucose and electrolyte disorders to evaluate the clinical safety and tolerability of early fructose combined with thrombolysis.An independent clinical endpoint adjudication committee blindly assesses all endpoint events to reduce evaluation bias. Statistical analyses adopt appropriate methods for non-equilibrium small sample data to explore the clinical efficacy, neuronal mitochondrial metabolic regulation mechanism and safety of early fructose injection intervention in acute ischemic stroke patients, so as to provide clinical evidence for early neuroprotective strategy optimization.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 46 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Ji Xunming,MD,PhD is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Presence of hemorrhagic diathesis, including but not limited to:
Patients receive early intravenous infusion of 250 mL 10% fructose injection immediately after admission, followed by standard intravenous thrombolysis and routine standardized medical treatment for acute ischemic stroke. Unified blood pressure and blood glucose management are performed in all participants, and antiplatelet therapy is initiated 24 hours after thrombolysis.
Drug: 10% Fructose Injection
Patients receive only standard intravenous thrombolysis and routine standardized medical treatment for acute ischemic stroke without additional fructose injection. All participants receive the same unified blood pressure, blood glucose control and antiplatelet therapy regimen as the intervention group.
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.
7-day change in National Institutes of Health Stroke Scale (NIHSS) score
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.
Time frame: Baseline to 7 days after thrombolysis
Levels of N-acetylaspartate (NAA) detected by proton magnetic resonance spectroscopy (¹H-MRS)
Absolute changes in the levels of N-acetylaspartate (NAA) in the ischemic penumbra and infarct core, calculated from pre-IVT baseline to 24 hours after IVT. Relative quantification; no absolute concentration determined. Metabolite signal intensities are reported in arbitrary units (a.u.) normalized to internal reference (e.g., total NAA or water signal). Unit of measure: Arbitrary units
Time frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)
Levels of choline (Cho) detected by proton magnetic resonance spectroscopy (¹H-MRS)
Absolute changes in the levels of choline (Cho) in the ischemic penumbra and infarct core, calculated from pre-IVT baseline to 24 hours after IVT. Relative quantification; no absolute concentration determined. Metabolite signal intensities are reported in arbitrary units (a.u.) normalized to internal reference (e.g., total Cho or water signal). Unit of measure: Arbitrary units
Time frame: Time Frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)
Levels of creatine (Cr) detected by proton magnetic resonance spectroscopy (¹H-MRS)
Absolute changes in the levels of creatine (Cr) in the ischemic penumbra and infarct core, calculated from pre-IVT baseline to 24 hours after IVT. Relative quantification; no absolute concentration determined. Metabolite signal intensities are reported in arbitrary units (a.u.) normalized to internal reference (e.g., total Cr or water signal). Arbitrary units
Time frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)
NAA/Cr ratio derived from ¹H-MRS
Absolute change in N-acetylaspartate/creatine (NAA/Cr) ratio in the ischemic penumbra and infarct core, calculated from pre-IVT baseline to 24 hours after IVT. Unit of measure: Ratio (no unit)
Time frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)
Cho/Cr ratio derived from ¹H-MRS
Absolute change in choline/creatine (Cho/Cr) ratio in the ischemic penumbra and infarct core, calculated from pre-IVT baseline to 24 hours after IVT. Time Frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours). Unit of measure: Ratio (no unit)
Time frame: Time Frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)
1-month change in National Institutes of Health Stroke Scale (NIHSS) score
Absolute change in NIHSS score, calculated as follow-up score minus pre-IVT baseline score, assessed at 1 month after 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.
Time frame: Pre-IVT baseline to 1 month post-IVT (±7 days)
1-month functional outcome assessed by modified Rankin Scale (mRS)
Description: Functional status classified into favorable and unfavorable outcomes at 1 month after IVT. Favorable outcome: mRS score 0-2 (no or mild disability, independent in activities of daily living). Unfavorable outcome: mRS score 3-6 (moderate to severe disability, dependent in activities of daily living, or death for mRS score 6). The full scale is the modified Rankin Scale; total score ranges from 0 to 6, and higher scores indicate greater functional disability.
Time frame: Pre-IVT baseline to 1 month post-IVT (±7 days)
Plan to share: Undecided — A definitive plan for sharing individual participant data (IPD) has not yet been established at this stage. The feasibility and specific modalities of IPD sharing will be further evaluated and determined based on study progress, ethics committee approval, and relevant regulatory requirements.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Ji Xunming,MD,PhD