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Completed

NCT Number: NCT02878772

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

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immunoregulation Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Vinpocetine

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vinpocetine

Drug

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

Aspirin

Drug

100mg, once daily, oral medication

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2016
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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