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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02878772
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Junwei Hao, Tianjin Medical University General Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Stroke Immunoregulation Inflammation Vinpocetine Drug: vinpocetine Drug: Aspirin Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke
Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: vinpocetine group
Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
 Drug: vinpocetine
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.
Other Name: Cavinton

Drug: Aspirin
100mg, once daily, oral medication
Placebo Comparator: Control group
Patients will receive aspirin only.
 Drug: Aspirin
100mg, once daily, oral medication


Outcome Measures
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Primary Outcome Measures :
  1. changes in lesion volume [ Time Frame: lesion volume from baseline to day 7 ]
    changes in lesion volume from baseline (DWI) to day 7 (Flair)

  2. brain inflammatory level [ Time Frame: day 7 ]
    brain inflammatory level (MRS) at day 7

  3. extent of clinical improvement [ Time Frame: 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 Outcome Measures :
  1. probability of excellent recovery [ Time Frame: at day 90 ]
    probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)

  2. cytotoxic edema [ Time Frame: day 3 ]
    cytotoxic edema of day 3 (ADC value).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Junwei Hao, Professor, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT02878772    
Other Study ID Numbers: TianjinMUGH1
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Inflammation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Vinpocetine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Phosphodiesterase Inhibitors
Vasodilator Agents
Neuroprotective Agents