Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients

Study Overview
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Brief Summary
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Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).

Official Title
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Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke

Conditions
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Stroke, Immunoregulation, Inflammation, Vinpocetine

Intervention / Treatment
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* Drug: vinpocetine
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion measurable neurological deficit (NIHSS > 5) interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy Exclusion Criteria: hemorrhagic stroke and severe hemorrhage in other organs other diseases of the central nervous system (CNS) diabetes mellitus tumor or hematological systemic diseases any infection before acute ischemic stroke concomitant use of antineoplastic or immune modulating therapies contraindication to MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vinpocetine group<br>Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days | Drug: vinpocetine<br>* 30 mg of the drug by intravenous infusion once daily, for fourteen consecutive days, beginning within one hour after the baseline MRI and no later than 48 hours after the onset of symptoms.<br>* Other names: Cavinton;Drug: Aspirin<br>* 100mg, once daily, oral medication<br>|
| Placebo Comparator: Control group<br>Patients will receive aspirin only. | Drug: Aspirin<br>* 100mg, once daily, oral medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in lesion volume | changes in lesion volume from baseline (DWI) to day 7 (Flair) | lesion volume from baseline to day 7 | 
| brain inflammatory level | brain inflammatory level (MRS) at day 7 | day 7 | 
| extent of clinical improvement | extent of clinical improvement at day 7 and 14, as measured by the changes on the NIHSS score from baseline to day 7 and 14 | from baseline to day 7 and 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probability of excellent recovery | probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS) | at day 90 | 
| cytotoxic edema | cytotoxic edema of day 3 (ADC value). | day 3 |