Immunoregulation, Inflammation, Stroke, Vinpocetine
Conditions
Brief summary
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).
Interventions
DRUGvinpocetine
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.
DRUGAspirin
100mg, once daily, oral medication
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in lesion volume | lesion volume from baseline to day 7 | changes in lesion volume from baseline (DWI) to day 7 (Flair) |
| brain inflammatory level | day 7 | brain inflammatory level (MRS) at day 7 |
| extent of clinical improvement | from baseline to day 7 and 14 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| probability of excellent recovery | at day 90 | probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS) |
| cytotoxic edema | day 3 | cytotoxic edema of day 3 (ADC value). |
Outcome results
None listed