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

August 24, 2016 updated by: Junwei Hao, Tianjin Medical University General Hospital

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

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).

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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 Names:
  • Cavinton
100mg, once daily, oral medication
Placebo Comparator: Control group
Patients will receive aspirin only.
100mg, once daily, oral medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in lesion volume
Time Frame: lesion volume from baseline to day 7
changes in lesion volume from baseline (DWI) to day 7 (Flair)
lesion volume from baseline to day 7
brain inflammatory level
Time Frame: day 7
brain inflammatory level (MRS) at day 7
day 7
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
from baseline to day 7 and 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at day 90
cytotoxic edema
Time Frame: day 3
cytotoxic edema of day 3 (ADC value).
day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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