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

NCT ID: NCT02878772

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

vinpocetine group

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

Group Type: ACTIVE_COMPARATOR

vinpocetine

Intervention Type: 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.

Aspirin

Intervention Type: DRUG

100mg, once daily, oral medication

Control group

Patients will receive aspirin only.

Group Type: PLACEBO_COMPARATOR

Aspirin

Intervention Type: DRUG

100mg, once daily, oral medication

Interventions

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.

Intervention Type: DRUG

Aspirin

100mg, once daily, oral medication

Intervention Type: DRUG

Other Intervention Names

Cavinton

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Medical University General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junwei Hao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 28691141 (View on PubMed)

Other Identifiers

TianjinMUGH1

Identifier Type: -

Identifier Source: org_study_id