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

Tianjin Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Inflammation; Stroke; Vinpocetine; Immunoregulation

Treatments: Drug: vinpocetine; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02878772

TianjinMUGH1

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

vinpocetine group

Active Comparator group

Description:

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

Treatment:

Drug: vinpocetine

Drug: Aspirin

Control group

Placebo Comparator group

Description:

Patients will receive aspirin only.

Treatment:

Drug: Aspirin