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

Primary Purpose

Stroke, Immunoregulation, Inflammation

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
vinpocetine
Aspirin
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    vinpocetine group

    Control group

    Arm Description

    Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days

    Patients will receive aspirin only.

    Outcomes

    Primary Outcome Measures

    changes in lesion volume
    changes in lesion volume from baseline (DWI) to day 7 (Flair)
    brain inflammatory level
    brain inflammatory level (MRS) at 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

    Secondary Outcome Measures

    probability of excellent recovery
    probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)
    cytotoxic edema
    cytotoxic edema of day 3 (ADC value).

    Full Information

    First Posted
    August 4, 2016
    Last Updated
    August 24, 2016
    Sponsor
    Tianjin Medical University General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02878772
    Brief Title
    Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients
    Official Title
    Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tianjin Medical University General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Immunoregulation, Inflammation, Vinpocetine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vinpocetine group
    Arm Type
    Active Comparator
    Arm Description
    Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive aspirin only.
    Intervention Type
    Drug
    Intervention Name(s)
    vinpocetine
    Other Intervention Name(s)
    Cavinton
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin
    Intervention Description
    100mg, once daily, oral medication
    Primary Outcome Measure Information:
    Title
    changes in lesion volume
    Description
    changes in lesion volume from baseline (DWI) to day 7 (Flair)
    Time Frame
    lesion volume from baseline to day 7
    Title
    brain inflammatory level
    Description
    brain inflammatory level (MRS) at day 7
    Time Frame
    day 7
    Title
    extent of clinical improvement
    Description
    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
    Time Frame
    from baseline to day 7 and 14
    Secondary Outcome Measure Information:
    Title
    probability of excellent recovery
    Description
    probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)
    Time Frame
    at day 90
    Title
    cytotoxic edema
    Description
    cytotoxic edema of day 3 (ADC value).
    Time Frame
    day 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    28691141
    Citation
    Zhang F, Yan C, Wei C, Yao Y, Ma X, Gong Z, Liu S, Zang D, Chen J, Shi FD, Hao J. Vinpocetine Inhibits NF-kappaB-Dependent Inflammation in Acute Ischemic Stroke Patients. Transl Stroke Res. 2018 Apr;9(2):174-184. doi: 10.1007/s12975-017-0549-z. Epub 2017 Jul 9.
    Results Reference
    derived

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