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

NCT02878772 | Completed Phase 2 DMC

• 1 other identifier: TianjinMUGH1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stroke; Immunoregulation; Inflammation; Vinpocetine

Outcome Measures

Primary Outcomes (3)

• changes in lesion volume

  changes in lesion volume from baseline (DWI) to day 7 (Flair)

  lesion volume from baseline to day 7

• brain inflammatory level

  brain inflammatory level (MRS) at day 7

  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

  from baseline to day 7 and 14

Secondary Outcomes (2)

• probability of excellent recovery

  at day 90

• cytotoxic edema

  day 3

Study Arms (2)

vinpocetine group

ACTIVE COMPARATOR

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

Drug: vinpocetine; Drug: Aspirin

Control group

PLACEBO COMPARATOR

Patients will receive aspirin only.

Drug: Aspirin

Interventions

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.

Also known as: Cavinton

vinpocetine group

Aspirin DRUG

100mg, once daily, oral medication

Control group; vinpocetine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Related Publications (1)

• 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.

  PMID: 28691141 DERIVED

MeSH Terms

Conditions

Stroke; Inflammation

Interventions

vinpocetine; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 25, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 25, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share