Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Primary Endpoint
- changes in lesion volume
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
vinpocetine group
Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
Intervention: vinpocetine (Drug)
vinpocetine group
Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
Intervention: Aspirin (Drug)
Control group
Patients will receive aspirin only.
Intervention: Aspirin (Drug)
Outcomes
Primary Outcomes
changes in lesion volume
Time Frame: lesion volume from baseline to day 7
changes in lesion volume from baseline (DWI) to day 7 (Flair)
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
brain inflammatory level
Time Frame: day 7
brain inflammatory level (MRS) at day 7
Secondary Outcomes
- cytotoxic edema(day 3)
- probability of excellent recovery(at day 90)
Investigators
Junwei Hao
Professor
Tianjin Medical University General Hospital