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

Completed

Phase 2/3 Results N/A

Trial Description

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

Interventions

  • Vinpocetine (Cavinton)Drug
    Other Names: Cavinton
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: vinpocetine group
    Description: Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: 100mg, once daily, oral medication
    ARM 1: Kind: Experimental
    Label: vinpocetine group
    Description: Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
    ARM 2: Kind: Experimental
    Label: Control group
    Description: Patients will receive aspirin only.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary changes in lesion volume lesion volume from baseline to day 7 Yes
Primary brain inflammatory level day 7 Yes
Primary extent of clinical improvement from baseline to day 7 and 14 No
Secondary probability of excellent recovery at day 90 No
Secondary cytotoxic edema day 3 No

Sponsors